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	05/31/2018
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 the product broke inside patient.The broken pieces were successfully removed from patient.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: while pulling mesh through the trocar the hunter bowel snapped and broke while in the patient.The handle and insert were removed the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be excessive force, or rotational force with the jaw under load.Mfg date: manufacture date is not known.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the product broke inside patient.The broken pieces were successfully removed from patient.

• 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: 7636030
• Report Number: 0002936485-2018-00504
• Device Sequence Number: 11211214
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2018

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: 0143178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1