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	Continuous Firing (1123)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was continuously activating.
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.
Additional Manufacturer Narrative
The device was received at the local service facility for investigation.The technical service report is attached(see communication log), and indicates: service code: a the repair includes: defective parts replacement, leakage current function test calvier rplcmt joint, membrane, revision.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.
Event or Problem Description
It was reported that the device was continuously activating.

• 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
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15848536
• Report Number: 0002936485-2022-00698
• Device Sequence Number: 12110121
• Product Code: GFA
• UDI-Device Identifier: 07613327057645
• UDI-Public: 07613327057645
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/21/2023

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: 0375708500E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 01/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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: Unknown