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

Model Number	34310MA-D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As per a manufacturer incident report #(b)(4) received from the factory in germany: the event occurred in switzerland.During a diagnostic laparoscopy, the insulation ring of the clickline scissors insert came loose and fell into the abdomen, which caused a delay in the surgery for 80 mins, and the abdomen needed to be opened by laparotomy to search and salvage the loosened part.
Additional Manufacturer Narrative
The investigation is pending.Actions will be implemented by the manufacturer as required.When the affected device has been received by the manufacturer, it can be determined what further investigations need to be conducted.
Additional Manufacturer Narrative
The reported failure that the orange insulation ring was damaged could be confirmed.The root cause for this issue is most probable that the handwheel of the handle, which was used in combination with the affected product, has come loose or has not been screwed on as far as it will go.This caused a gap of approximately 3mm between the handle wheel and the handle which subsequently pushed the marking sleeve towards the distal end when the shaft and the handle were assembled.Due to the incorrect screwing of the handle wheel, the driving lugs of the handwheel were pressed approximately 3mm further in the direction of the distal end, which caused the sleeve to be pushed out of the original position.Due to this overload, the insulation ring broke and fell into the patient.In the corresponding ifu of the product the risk of a incorrect handling of the product is pointed out and it is stated to check all articles for function, damages and correct assembly immediately before and after every use.In the corresponding ifu of the product the risk of a incorrect handling of the product is pointed out and it is stated to check all articles for function, damages and correct assembly immediately before and after every use.

• Brand Name: CLICKLINE SCISSORS INSERT
• Common Device Name: RIGID ENDOSCOPY SCISSORS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15242929
• Report Number: 9610617-2022-00244
• Device Sequence Number: 12375904
• Product Code: GEI
• UDI-Device Identifier: 04048551336434
• UDI-Public: 4048551336434
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K151044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 34310MA-D
• Device Lot Number: ZO03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown