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

Model Number 0375708500

Device Problem Smoking (1585)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2020

Event Type  malfunction  

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 there was a thermal event.Please note this was noticed during inspection.

Event Description

It was reported there was a thermal event.Please note this was noticed during inspection.

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.
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10451179
• MDR Text Key: 205274398
• Report Number: 0002936485-2020-00349
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 07613327057645
• UDI-Public: 07613327057645
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1