MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, NEEDLE HOLDER, CURVED LEFT; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Catalog Number	0250080341
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/19/2018
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 an additional surgery was performed to remove a metallic layer from inside the patient.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: after end of surgery, when the nurse inspected device and found the metallic layer fall off from tc needle holder tip.The nurse reported this issue to surgeon immediately.At that time, the surgery has finished , the abdominal cavity has closed.After confirmed through x-ray, the metallic layer was found in patient¿s abdominal cavity.The patient performed the second surgery to take out metallic layer.Because of nurse discover this issue in time, the big medical accident wasn¿t happen.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be excessive contact with another surgical device and/or excessive reprocessing.Mfg date: manufacture date is not known.
Event or Problem Description
It was reported that an additional surgery was performed to remove a metallic layer from inside the patient.

• Brand Name: PKG, NEEDLE HOLDER, CURVED LEFT
• 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: 7802910
• Report Number: 0002936485-2018-00585
• Device Sequence Number: 2488889
• Product Code: OCZ
• UDI-Device Identifier: 07613327058277
• UDI-Public: 07613327058277
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K973259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2018

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: 0250080341
• Device Lot Number: 1540078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 12/07/2018
• 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