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Insighter

Shenzhen Insighters Medical Technology Co., Ltd. · Model iS3-F · UDI-DI 06970831723154

CAL Prescription

510(k) clearances

1,099

Adverse events (6 deaths)

Recalls

Facilities

Recalls

Date	Firm	Reason
2021-09-10	Karl Storz Endoscopy	During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may
2020-07-27	Karl Storz Endoscopy	Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable
2020-07-27	Karl Storz Endoscopy	Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable
2020-07-27	Karl Storz Endoscopy	Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable
2020-07-27	Karl Storz Endoscopy	Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable
2020-07-27	Karl Storz Endoscopy	Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable
2020-07-27	Karl Storz Endoscopy	Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable
2020-07-27	Karl Storz Endoscopy	Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable
2020-07-27	Karl Storz Endoscopy	Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable
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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Data 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.