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

Catalog Number	0250080767
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/11/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8224237
• Report Number: 0002936485-2019-00006
• Device Sequence Number: 16200482
• Product Code: GEN
• UDI-Device Identifier: 07613327056648
• UDI-Public: 07613327056648
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0250080767
• Device Lot Number: 15427331
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other