MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PACKAGING, FORMULA 180 SHAVER (HAND CONTROL); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	0375708500
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure needed to be rescheduled due to the device not working and not having a replacement.The patient was under anesthesia, but no incisions were made.
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 procedure needed to be rescheduled due to the device not working and not having a replacement.The patient was under anesthesia, but no incisions were made.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: did not power up.Probable root cause: breaking resistors on the flex circuitry due to stress on flex cable (due to manufacturing and assembly error combined with normal use stress); broken handpiece cable, or conductors inside; no power from the console; broken traces on the membrane switch; membrane switch is corroded due to moisture ingress; flattened buttons/ switches; poor soldering or other electrical connection; broken pin; pcba component failure; button press reaction force so high the buttons can't be pressed to deliver information; console not delivering power to shaver (refer to rsk10642, rsk10686); expired disposable after r.1.1.1; use error.The reported failure mode will be monitored for future reoccurrence.H3 other text: 81.

• Brand Name: PACKAGING, FORMULA 180 SHAVER (HAND CONTROL)
• 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: 12845052
• Report Number: 0002936485-2021-00651
• Device Sequence Number: 20041255
• Product Code: GFA
• UDI-Device Identifier: 07613327057645
• UDI-Public: 07613327057645
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 01/20/2022

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 Model Number: 0375708500
• Device Catalogue Number: 0375708500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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: Male