MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FORMULA 180 SHAVER INTERNATIONAL KIT.; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	0375708500
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2020
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 there was a thermal event.Please note this was noticed during inspection.
Event or Problem Description
It was reported there was a thermal event.Please note this was noticed during inspection.
Additional Manufacturer Narrative
The device was received at the local service facility for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.The technical service report is attached (see comm log), and indicates: "fault: faulty keypad and motor over amp during inspection of the shaver.Repair level: level 1.Action taken: replacement of defective motor and keypad revision of the shaver.Tests: function test general inspection qip." probable root cause: 1.Material/design error.2.Manufacturing/assembly error (missing lubrication/grease).3.Clogged suction path.4.Hot irrigant fluid external to shaver.5.Use error.

• Brand Name: FORMULA 180 SHAVER INTERNATIONAL KIT.
• 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: 10451179
• Report Number: 0002936485-2020-00349
• Device Sequence Number: 2822427
• Product Code: GFA
• UDI-Device Identifier: 07613327057645
• UDI-Public: 07613327057645
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 0375708500
• Device Catalogue Number: 0375708500E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1