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

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problems Superficial (First Degree) Burn (2685); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2022

Event Type  malfunction  

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 Description

It was reported that the device was getting hot and burnt through the surgeon's glove.

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 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
• Type of Device: 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
• MDR Text Key: 296507342
• Report Number: 0002936485-2022-00263
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 37613327054843
• UDI-Public: 37613327054843
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1