MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FORMULA SHAVER HANDPIECE (WITH BUTTONS); 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 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacture 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 the shaver handpiece over-heated during use.There was no patient involvement or adverse consequences due to the product.

Manufacturer Narrative

The following repair and service diagnostic codes were identified based on a service request.Damaged cable (not cut), replaced cable, tier 2 shaver repair.The following was observed: the cable was damaged and a tier 2 saver repair was performed to replace the cable.This does confirm the alleged failure mode of over heating.Probable root cause: 1.Material/design error, 2.Manufacturing/assembly error, (missing lubrication/grease), 3.Clogged suction path.Use error.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 shaver handpiece over-heated during use.There was no patient involvement or adverse consequences due to the product.

• Brand Name: FORMULA SHAVER HANDPIECE (WITH BUTTONS)
• 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: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 5132525
• MDR Text Key: 27985382
• Report Number: 0002936485-2015-00896
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/10/2015

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: 0375704500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1