MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, SLIDING LOCK ATRAUMATIC GRASPER; FORCEPS, GENERAL & PLASTIC SURGERY

Catalog Number 0250080767

Device Problem Break (1069)

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

Event Date 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the grasper broke during a case.Per additional information received, all pieces were retrieved and the procedure was completed successfully.

Manufacturer Narrative

Alleged failure: broken.Probable root cause: poor autoclave reliability shear pin failure in handle.Use error.The device manufacture date is not known.The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the grasper broke during a case.Per additional information received, all pieces were retrieved and the procedure was completed successfully.

• Brand Name: PKG, SLIDING LOCK ATRAUMATIC GRASPER
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7770496
• MDR Text Key: 116897523
• Report Number: 0002936485-2018-00575
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 07613327056648
• UDI-Public: 07613327056648
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

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: 0250080767
• Device Lot Number: 15405061
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 07/16/2018
• Supplement Dates FDA Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR