MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 5.5MM RESECTOR CUTTER, FORMULA (5BX); BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number 0375562000

Device Problem Overheating of Device (1437)

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

Event Date 03/11/2015

Event Type  malfunction  

Event Description

It was reported that the blade had heated up.

Manufacturer Narrative

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

Manufacturer Narrative

The product was returned and the failure mode was confirmed.The cutter was visually inspected for damages, and the shaft at the proximal end has broken off.The proximal plastic hub appears to be melted.Also, the cutting window has evidence of interference.The inner shaft is stuck and cannot be removed.Unable to perform a functional inspection due to the condition of the cutter.The probable root causes for the broken shaft could be lateral pressure was used causing the proximal end to break, or the tip of the burr was stuck causing the shaver to break the proximal end.The probable root causes for the melted hub could be friction due to excessive force.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the blade had heated up.

• Brand Name: 5.5MM RESECTOR CUTTER, FORMULA (5BX)
• 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: thomas shafer ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 4648921
• MDR Text Key: 5597741
• Report Number: 0002936485-2015-00228
• Device Sequence Number: 1
• Product Code: GFF
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2015

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: 0375562000
• Device Lot Number: 15012CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2015
• Initial Date FDA Received: 04/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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