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

Catalog Number 0375708500A

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2018

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the product overheated.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: shaver is severely overheating and a dark oily liquid leaked out of the head of the device.Probable root cause: material/design error.Manufacturing/assembly error.Clogged suction path.Hot irrigant fluid external to shaver.Use error.

Event Description

It was reported that the product overheated.

• Brand Name: PACKAGING, FORMULA 180 SHAVER (HAND CONTROL) - ROHS
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7903224
• MDR Text Key: 121708023
• Report Number: 0002936485-2018-00623
• Device Sequence Number: 1
• Product Code: GFF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

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 Catalogue Number: 0375708500A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/24/2018
• Supplement Dates Manufacturer Received: 08/30/2018
• Supplement Dates FDA Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1