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

Catalog Number	0250080314
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/22/2019
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 a piece broke and remained inside the patient.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: broke grasper.- probable root cause: - incorrect packaging - severe shipping conditions - use error.The reported failure mode will be monitored for future re-occurrence.The device manufacturer date is not known.
Event or Problem Description
It was reported that a piece broke and remained inside the 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: 8713424
• Report Number: 0002936485-2019-00248
• Device Sequence Number: 13918325
• Product Code: OCZ
• UDI-Device Identifier: 07613327052879
• UDI-Public: 07613327052879
• Combination Product (Y/N): N
• 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): 08/22/2019

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: Other
• Device Catalogue Number: 0250080314
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 08/22/2019
• 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