MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., BARREL BUR, 12 FLUTE F - SERIES - 5.5MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0375951012
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
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 device was getting hot and burnt through the surgeon's glove.
Additional Manufacturer Narrative
Alleged failure: getting to hot/burnt through glove.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be could be poor or no suction during use, tissue blocking the suction pathway would prevent cooling and to the cutter's cutting performance.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the device was getting hot and burnt through the surgeon's glove.

• Brand Name: PKG., BARREL BUR, 12 FLUTE F - SERIES - 5.5MM
• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 14496628
• Report Number: 0002936485-2022-00263
• Device Sequence Number: 14742127
• Product Code: GFA
• UDI-Device Identifier: 37613327054843
• UDI-Public: 37613327054843
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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
• Report Date (Section B): 07/12/2022

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: 0375951012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown