MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., TOMCAT SHAVER BLADE, F - SERIES - 4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0375545000
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the device broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
Please note that the initial report's type of reportable event was malfunction; per investigation results, the break happened at the inner tube and no pieces were missing.The inner tube would not be able to come out and fall into the joint.This event description most likely indicates ¿loose pieces (tip breaking / tube breaking/ plastic breaking)¿.The review of historical complaint data, risk documentation, and the reported information regarding this event do not suggest a recurrence of this event would be likely to result in a serious injury.No adverse consequences were reported, it does not seem likely that adverse consequences would result if it were to recur.Therefore making this event not reportable.Alleged failure: it was found that the shaver blade, which had broken (tube) the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be excessive force applied by the user, poor or no suction, used pressure such as bending or prying.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
Per investigation results, the break happened at the inner tube and no pieces were missing.The inner tube would not be able to come out and fall into the joint.This event description most likely indicates ¿loose pieces (tip breaking / tube breaking/ plastic breaking)¿.The review of historical complaint data, risk documentation, and the reported information regarding this event do not suggest a recurrence of this event would be likely to result in a serious injury.No adverse consequences were reported, it does not seem likely that adverse consequences would result if it were to recur.No report will be filed.Therefore making this event not reportable.

• Brand Name: PKG., TOMCAT SHAVER BLADE, F - SERIES - 4.0MM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10782181
• Report Number: 0002936485-2020-00452
• Device Sequence Number: 3016006
• Product Code: GFA
• UDI-Device Identifier: 37613327061797
• UDI-Public: 37613327061797
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0375545000
• Device Lot Number: 19091CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1