MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE SCISSORS INSERT

Model Number 34310MS-D

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

Device has not yet been evaluated; it is in transit to the manufacturer, (b)(4).

Event Description

As per a vigilance report filed with national competent authority, swissmedic, by the factory in (b)(6): during a laparoscopic procedure, the jaws of the clickline scissors insert could no longer be closed intra-abdominally.To remove the instrument, the trocar had to be removed and a pair of pliers was used to close the jaws in order to bring the scissors insert through the orifice.

Manufacturer Narrative

As per the manufacturer's evaluation: upon evaluation the scissor blades were found to be damaged.A hardness test was unobtrusive.The scissor blades are dented in a way they cannot be closed anymore.The damages of the two cutting edges overlap exactly.Most probably the scissor blades were cutting themselves due to high force initiation and bending of the blades.The device was manufactured in april 2019.The root cause most probably is too high force initiation and bending of the blades.No indication for a material or manufacturing related issue was found during the investigation.

• Brand Name: CLICKLINE SCISSORS INSERT
• Type of Device: SCISSORS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 9777546
• MDR Text Key: 198141610
• Report Number: 9610617-2020-00030
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551336410
• UDI-Public: 4048551336410
• Combination Product (y/n): N
• PMA/PMN Number: K935071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 34310MS-D
• Device Catalogue Number: 34310MS-D
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention