MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PACKAGING FORMULA SHAVER HAND CONTROL; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0375704500
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a thermal event of smoking.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Please note update to section d1: product long description, section d4: catalog #, and section d4: gtin.
Event or Problem Description
It was reported that there was a thermal event of smoking.
Event or Problem Description
It was reported that there was a thermal event of smoking.
Additional Manufacturer Narrative
It was confirmed that entire finished good was not returned as only components were returned.Therefore the investigation could be be performed since the entire finished good was not returned.This complaint investigation was closed based on the entire device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: thermal event.Probable root cause: clogged suction path.Hot irrigant fluid external to shaver.Use error.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: PACKAGING FORMULA SHAVER HAND CONTROL
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 20848659
• Report Number: 0002936485-2024-00895
• Device Sequence Number: 14432647
• Product Code: GFA
• UDI-Device Identifier: 07613327057638
• UDI-Public: 07613327057638
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2025

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: Other
• Device Catalogue Number: 0375704500
• Device Lot Number: 24I5604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 06/08/2025; 06/08/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 07/07/2025; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown