MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 'PKG, DEBAKEY FORCEPS'; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Catalog Number	0250080314
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that pieces brokeoff inside patient.Broken pieces were successfully removed from patient and the case was completed successfully.
Additional Manufacturer Narrative
Alleged failure: pieces broke off.Probable root cause: poor autoclave reliability.Shear pin failure in handle.Use error.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.The device manufacture date is not known.
Event or Problem Description
It was reported that pieces broke off inside patient.Broken pieces were successfully removed from patient and the case was completed successfully.

• Brand Name: 'PKG, DEBAKEY FORCEPS'
• Common Device Name: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7724126
• Report Number: 0002936485-2018-00553
• Device Sequence Number: 16507001
• Product Code: OCZ
• UDI-Device Identifier: 07613327052879
• UDI-Public: 07613327052879
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K973259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0250080314
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR