MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SUCTION AND COAG.CANNULA,L. 36 CM; ENDOSCOPIC ELECTROSURGICAL ELECT

Model Number	37370DH
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that during the laparoscopy, the electric hook was used, but when the electricity was first triggered, the hook fell off.It had to be removed separately from the abdominal cavity, fortunately, it was found immediately.Additional patient information is not available.
Additional Manufacturer Narrative
The electrode tip is broken off at the distal end the tip has been bent up.Traces of use can be seen on the entire shaft.The breakage of the electrode tip is also due to excessive force (for example: levering, pressing).In the ifu it is pointed out that increased force can cause damage to the product.Therefore the most probably root cause is user-related.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: SUCTION AND COAG.CANNULA,L. 36 CM
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECT
• 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: 16453016
• Report Number: 9610617-2023-10047
• Device Sequence Number: 5872794
• Product Code: GEI
• UDI-Device Identifier: 04048551155646
• UDI-Public: 4048551155646
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K944823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 37370DH
• Device Catalogue Number: 37370DH
• Device Lot Number: PP01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown