N/A 9734692Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994993564), received between Mar 31, 2020 and Mar 31, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K960738); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2020Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (CONFIRMED VIA SITE) INDICATED THE INSTRUMENT WOULD NOT YET BE RETURNED AS THE REPLACEMENT INSTRUMENT HAD NOT YET BEEN RECEIVED. FURTHER INFORMATION WAS BEING IMPACTED BY THE CURRENT COVID-19 CRISIS AS THE EVENT CITY WAS UNDER QUARANTINE.

  Patient problems: No Patient Involvement

  MAUDE report 9902951 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K960738. One submission often covers many models, so check the product and lot details in each record.

• Z-2612-2011 · Jun 8, 2011 · Terminated
  45cm Laparoscopic Instruments Sterilization tray. Manufactured by: Stryker Endoscopy, 5900 Optical Court,San Jose, CA 95138 Designed to hold laparoscopic surgical manual instrume