MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., XL ROUND DIAMOND BUR 4.0MM; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number 0485840000

Device Problems Melted (1385); Overheating of Device (1437); Material Deformation (2976)

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

Event Date 03/24/2022

Event Type  malfunction  

Event Description

It was reported that the device overheated and melted the plastic on the device.

Manufacturer Narrative

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

Event Description

It was reported that the device overheated and melted the plastic on the device.

Manufacturer Narrative

Alleged failure: the blade to overheat and damage/melt the plastic on the shaver blade.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be excessive loading for an extended period of time without suction.It is also possible that a clog of the bur suction path hole would cause blockage of the fluid path, creating excessive heat buildup in the inner shaft and exposing the heat shrink to the heat enough which causing it to loosen.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: PKG., XL ROUND DIAMOND BUR 4.0MM
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: 14215172
• MDR Text Key: 294282951
• Report Number: 0002936485-2022-00203
• Device Sequence Number: 1
• Product Code: GFF
• UDI-Device Identifier: 37613327301534
• UDI-Public: 37613327301534
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0485840000
• Device Lot Number: 21098CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1