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

Catalog Number	0250080340
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/07/2018
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 the tip broke and potentially remained inside of the patient.
Additional Manufacturer Narrative
Alleged failure: the tip of the insert was broken off and the broken tip could remain inside the patient body.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.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
Event or Problem Description
It was reported that the tip broke and potentially remained inside of the patient.

• Brand Name: PKG, NEEDLE HOLDER, STRIAGHT
• 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: 7555408
• Report Number: 0002936485-2018-00466
• Device Sequence Number: 1813678
• Product Code: OCZ
• UDI-Device Identifier: 07613327058284
• UDI-Public: 07613327058284
• Combination Product (Y/N): N
• 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): 09/06/2018

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: 0250080340
• Device Lot Number: 1641307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 09/06/2018
• 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