Home › LSI Solutions, Inc. › McCarus-Volker FORNISEE® SYSTEM
McCarus-Volker FORNISEE® SYSTEM
LSI Solutions, Inc. · Model 110112 · UDI-DI 00850200006391
LKF
Prescription
1
510(k) clearances
1,772
Adverse events (2 deaths)
13
Recalls
102
Facilities
Description
FS® SOUND Set of (4) This set includes (1) each non-sterile, reusable 6cm, 8cm, 10cm, and 12cm FS® SOUNDS, all of which have Direct Marking.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2022-03-31 | CooperSurgical, Inc. | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay |
| 2022-03-31 | CooperSurgical, Inc. | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay |
| 2022-03-31 | CooperSurgical, Inc. | Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay |
| 2019-05-30 | Clinical Innovations, LLC | An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result |
| 2015-05-18 | CooperSurgical, Inc. | Design of device may expose user to injury to fingers or body parts |
| 2014-07-03 | CooperSurgical, Inc. | Unsealed pouches. |
| 2014-05-13 | CooperSurgical, Inc. | Sterility of the device may be compromised due to unsealed pouch |
| 2012-10-31 | Cooper Surgical, Inc. | Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning |
| 2012-10-31 | Cooper Surgical, Inc. | Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.