MAUDE Adverse Event Report: STRYKER SUSTAINABILITY REPROCESSED ENDOPATH CURVED SCISSORS 5MM; STRYKER

Lot Number 4630612

Device Problem Peeled/Delaminated (1454)

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

Event Date 07/28/1948

Event Type  malfunction  

Event Description

A stryker endopath curved scissors with unipolar cautery was being used in a robotic gynecology procedure.During the surgery, the coating of the instrument scrapped on the edge of an intra-abdominal trocar which caused incidental damage to the coating.The instrument was removed from the surgical field and not used again for the rest of the case.The surgeon did inspect the surgical site and did not see any of the coating from the instrument left behind in the pt.The surgeon had seen the incident happening and he was confident that nothing had been left behind in the pt, and as the coating on this instrument is not metal an x-ray was not needed.Following the surgical procedure, the pt remained afebrile and had a normal white cell count.

• Brand Name: ENDOPATH CURVED SCISSORS 5MM
• Type of Device: STRYKER
• Manufacturer (Section D): STRYKER SUSTAINABILITY REPROCESSED; tempe FL 85283
• MDR Report Key: 5966036
• MDR Text Key: 55377995
• Report Number: MW5064870
• Device Sequence Number: 1
• Product Code: HET
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2019
• Device Lot Number: 4630612
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 177