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

Catalog Number	0250080265
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mfg date: 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 a piece of the scissor fell off during a case.Additional information received states it was not known if the broken piece was retrieved from the patient.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: broken.Probable root cause: poor autoclave reliability.Shear pin failure in handle.Use error.The device manufacture date is not known.
Event or Problem Description
It was reported that a piece of the scissor fell off during a case.Additional information received states it was not known if the broken piece was retrieved from the patient.

• 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: 7802398
• Report Number: 0002936485-2018-00586
• Device Sequence Number: 13918844
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0250080265
• Device Lot Number: 1644704
• Was Device Available for Evaluation?: No
• 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