MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., BARREL BUR, 12 FLUTE F - SERIES - 4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0375941012
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the device burned the patient.
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.The reported failure mode will be monitored for future reoccurrence alleged failure: patient burn.Probable root cause: - manufacturing defect (grease application) - high friction due to components interaction - surface not smooth - poor/lack of suction - clogged shaver blade preventing fluid suction and cooling.
Event or Problem Description
It was reported that the device burned the patient.

• Brand Name: PKG., BARREL BUR, 12 FLUTE F - SERIES - 4.0MM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9123956
• Report Number: 0002936485-2019-00426
• Device Sequence Number: 16901892
• Product Code: GFA
• UDI-Device Identifier: 37613327054751
• UDI-Public: 37613327054751
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0375941012
• Device Lot Number: 19085CE2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other