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

Catalog Number 0375704500

Device Problem Overheating of Device (1437)

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

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the product got hot.

Manufacturer Narrative

Alleged failure: the shaver got way to hot to use, had to swap out the unit.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be (1) excessive force applied to the cutter/burr by the user with poor or no suction during use.Excessive force may cause friction due to bur shaft assembly and housing assembly interaction.(2) tissue blocking the suction pathway would prevent hot fluid from being removed from the joint.(3) poor arthroscopy pump suction.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the product got hot.

• Brand Name: PACKAGING, FORMULA SHAVER (HAND CONTROL)
• 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: 8474335
• MDR Text Key: 140674351
• Report Number: 0002936485-2019-00129
• Device Sequence Number: 1
• Product Code: GFF
• UDI-Device Identifier: 07613327057638
• UDI-Public: 07613327057638
• 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: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0375704500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1