STRYKER ENDOSCOPY-SAN JOSE AIR MENISCUS SYSTEM, CURVED; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
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Model Number 4720 |
Device Problems
Problem with Sterilization (1596); Tear, Rip or Hole in Device Packaging (2385)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that there was a breach in the sterile barrier.
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Event Description
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It was reported that there was a breach in the sterile barrier.
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Manufacturer Narrative
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Alleged failure: it was reported that when opening supplies for the or case the customer noted that the foil packaging for a sterile air meniscal repair device had a puncture in the upper corner.The case was completed using a different unit.The probable root causes could be: severe shipping conditions or user mishandling.The device manufacture date is not known.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
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Search Alerts/Recalls
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