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

Model Number	0250080311
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/02/2019
Type of Reportable Event	Serious Injury
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 there was a potential for pieces of the device being left in the patient.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: good afternoon, a locking d&g in a dr.Pratt robotic hernia case broke apart in the patient just now here is the picture of the instrument compared to another.I believe the va will be filing an incident report.This has not happened here before, let me know how to proceed.The failure 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.The device manufacture date is not known.
Event or Problem Description
It was reported that there was a potential for pieces of the device being left in the patient.

• Brand Name: PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION
• 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: 9522217
• Report Number: 0002936485-2019-00597
• Device Sequence Number: 2703236
• Product Code: OCZ
• UDI-Device Identifier: 07613327052848
• UDI-Public: 07613327052848
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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 Model Number: 0250080311
• Device Catalogue Number: 0250080311
• Device Lot Number: 1042193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 03/12/2020
• 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