MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE KIT, FORMULA H/C SHAVER; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number 0375704500E

Device Problem Overheating of Device (1437)

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

Event Date 02/22/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the product heated up.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: the practitioner broke 2 strawberries during use.Probable root cause: - inadequate window profile - inadequate welding process - improper material strength - inadequate size selected for the application - material brittleness - excessive force applied by the user - incorrect rfid tag.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the product heated up.

• Brand Name: KIT, FORMULA H/C SHAVER
• 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: 8453152
• MDR Text Key: 139976115
• Report Number: 0002936485-2019-00114
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0375704500E
• Device Lot Number: 15188CE2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1