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

Model Number 0375708500

Device Problems Mechanical Problem (1384); Failure to Power Up (1476)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2021

Event Type  malfunction  

Event 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.

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 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.

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)
• 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: 12845052
• MDR Text Key: 282103595
• Report Number: 0002936485-2021-00651
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 07613327057645
• UDI-Public: 07613327057645
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 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
• Device Operator: Health Professional
• Device Model Number: 0375708500
• Device Catalogue Number: 0375708500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male