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

Model Number	34310MS-D
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not yet been evaluated; it is in transit to the manufacturer, (b)(4).
Event or Problem 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.
Additional 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
• Common Device Name: SCISSORS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 9777546
• Report Number: 9610617-2020-00030
• Device Sequence Number: 560887
• Product Code: GCJ
• UDI-Device Identifier: 04048551336410
• UDI-Public: 4048551336410
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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 Model Number: 34310MS-D
• Device Catalogue Number: 34310MS-D
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention