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 Melted (1385); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Superficial (First Degree) Burn (2685); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2021

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 that there was a thermal event.

Event Description

It was reported that there was a thermal event.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was not confirmed.Alleged failure: the bur it was over spinning nad melted the plastic.The probable root cause/s could be the handpiece was corrupt due to (third-party components- power cable), misuse, the suction valve was not activated.The device manufacture date is not known.The failure mode will be monitored for future reoccurrence.

• 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
• MDR Report Key: 12304967
• MDR Text Key: 267531889
• Report Number: 0002936485-2021-00419
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 10/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Date Manufacturer Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1