MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PACKAGING FORMULA 180 SHAVER HAND CONTROL; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0375708500
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the formula 180 shaver hand piece was getting really hot and burnt the patients skin.It was a little burn that did not require any medical intervention.
Event or Problem Description
It was reported that the formula 180 shaver hand piece was getting really hot and burnt the patients skin.It was a little burn that did not require any medical intervention.
Additional Manufacturer Narrative
The sales representative confirmed product will not be coming in-house for evaluation.This complaint investigation was closed based on the 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: device becomes hot during use 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 180 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23719537
• Report Number: 0002936485-2025-00966
• Device Sequence Number: 16004778
• Product Code: GFA
• UDI-Device Identifier: 07613327057645
• UDI-Public: 07613327057645
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 0375708500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 04/02/2026
• 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 Age: 39 YR
• Patient Sex: Female