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SpyScope DS
BOSTON SCIENTIFIC CORPORATION · Model M00546600 · UDI-DI 08714729863236
FBN
Prescription
10
510(k) clearances
2,300
Adverse events (9 deaths)
9
Recalls
43
Facilities
Description
Access and Delivery Catheter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-23 | TANGENT ENDOSCOPY, LLC | Affected devices exhibited fractures at the distal shaft tip without complete detachment. |
| 2024-12-18 | Olympus Corporation of the Americas | Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device. |
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo |
| 2022-03-31 | Olympus Corporation of the Americas | Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps |
| 2020-08-31 | Olympus Corporation of the Americas | The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associated with breakage of the insertion section and protrusion of metal parts, as well as |
| 2017-12-20 | Boston Scientific Corporation | Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding. |
| 2016-12-12 | Olympus Corporation of the Americas | Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perf |
| 2016-04-06 | Pentax Medical Company | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel. |
| 2016-04-06 | Pentax Medical Company | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel. |
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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.