MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, METZENBAUM SCISSORS, CURVED LONG; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number	0250080265
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
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 of the scissor broke off.The broken pieces were retrieved.
Event or Problem Description
It was reported that the tip of the scissor broke off.The broken pieces were retrieved.
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: tip broke.Probable root cause: poor autoclave reliability.Shear pin failure in handle.Use error.Damage during manufacturing/ servicing.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.

• Brand Name: PKG, METZENBAUM SCISSORS, CURVED LONG
• 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: 9474606
• Report Number: 0002936485-2019-00559
• Device Sequence Number: 2927938
• Product Code: OCZ
• UDI-Device Identifier: 07613327052633
• UDI-Public: 07613327052633
• 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): 02/20/2020

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 Model Number: 0250080265
• Device Catalogue Number: 0250080265
• Device Lot Number: NR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1