MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAPAROSCOPIC ENDOCUT SCISSOR TIP; SCISSORS, GENERAL, SURGICAL

Model Number 3142

Device Problem Failure to Cut (2587)

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

Event Date 11/24/2018

Event Type  malfunction  

Event Description

During laparoscopic cholecystectomy, while utilizing the stryker sustainability, endocut scissor tip per mfr's instructions, the scissor tip would not cut.This device was replaced with a "like" item with a different lot number which worked without issue.

• Brand Name: LAPAROSCOPIC ENDOCUT SCISSOR TIP
• Type of Device: SCISSORS, GENERAL, SURGICAL
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; tempe AZ 85283
• MDR Report Key: 8110660
• MDR Text Key: 128749327
• Report Number: MW5081646
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• 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: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2019
• Device Model Number: 3142
• Device Catalogue Number: 3142
• Device Lot Number: 3693883
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR