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

Catalog Number 0250080767

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/11/2018

Event Type  Injury  

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 a piece of the grasper remained inside of the patient.Please note that the surgeon elected not to perform the xray.

Manufacturer Narrative

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

Event Description

It was reported that a piece of the grasper remained inside of the patient.Please note that the surgeon elected not to perform the xray.

• 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: 8224237
• MDR Text Key: 132296245
• Report Number: 0002936485-2019-00006
• 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: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0250080767
• Device Lot Number: 15427331
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other