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 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

Gtin: (b)(4).Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the handpiece overheated.

Manufacturer Narrative

Alleged failure: the handpiece overheated.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be (1) the hi-pot cable or (2) the shaver was run with the suction valve off.The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.(b)(4).

Event Description

It was reported that the handpiece overheated.

• 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: 5721169
• MDR Text Key: 47304067
• Report Number: 0002936485-2016-00549
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

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: 06/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 06/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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