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

Catalog Number	0375701500
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaver handpiece had overheated a few weeks prior which apparently resulted in a burn to the patient¿s skin.The only treatment provided was a redressing of the surgical wound.It was described as a 2nd degree and documented that the wound was healing appropriately.
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 a shaver handpiece had overheated a few weeks prior which apparently resulted in a burn to the patient¿s skin.The only treatment provided was a redressing of the surgical wound.It was described as a 2nd degree and documented that the wound was healing appropriately.
Additional Manufacturer Narrative
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: FORMULA SHAVER PACKAGING
• 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: 19987144
• Report Number: 0002936485-2024-00566
• Device Sequence Number: 8543628
• Product Code: GFA
• UDI-Device Identifier: 07613327057621
• UDI-Public: 07613327057621
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

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: 0375701500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 11/01/2024
• 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