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

Catalog Number 0250080265

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2018

Event Type  Injury  

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 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.

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 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
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7802398
• MDR Text Key: 117778377
• Report Number: 0002936485-2018-00586
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 07613327052633
• UDI-Public: 07613327052633
• Combination Product (y/n): N
• PMA/PMN Number: K973259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0250080265
• Device Lot Number: 1644704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1