MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MONOPOLAR DISSECTING BLUNT SPATULA ELECTRODE, 5MM X 36CM; DISSECTING ELECTRODE

Model Number	26775UE
Medical Device Problem Codes	Material Puncture/Hole (1504); Temperature Problem (3022)
Health Effect - Clinical Code	Bowel Burn (1756)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Preliminary results of initial inspection of the product: found a 1mm hole in the insulation.
Event or Problem Description
As per manufacturer incident report #(b)(4) received from the factory in germany: the reported event happened in singapore.According to the information available, user reported that the during an anterior laparoscopy and colonoscopy procedure, patient sustained deep burns in the small bowel.As a result, they found 3 burn areas inside the small bowel, and had to resect part of small bowel, plus staple and anastomosis.
Additional Manufacturer Narrative
The device in question was returned to manufacturer on 01.06.2022.Device analysis results.After inspecting the instrument, the customer's description of the fault can be confirmed, there are several damages on the entire surface of the shaft.Due to the damage to the insulation of the shaft, the heat was transferred into the operating field.The insulation had probably already been damaged in advance, potential resulted by breakdown.The electrodes are subjected to a 100% high-voltage test in the final inspection; if the damage had already been present in advance, this would have been noticed there.Device history review results manufacturing order: (b)(4); inspection lot: 40001647970 - no abnormalities were found according to the inspection lot.The damage to the product is not caused by a production problem or material defect.The instruction (96136308df; version: 2.0 - 11/2017) includes following safety-relevant information: "warning: ensure that the electrodes are in good working order before each use.In particular, check the insulation for any damage.If there are any signs of damage, the electrode must not be used under any circumstances.Ensure the secure placement of all components.Warning: risk of burns for the patient due to defective insulation: only active the hf current when the uninsulated part of the electrode tip is in the user's field of vision and the required tissue contact has been made.".

• Brand Name: MONOPOLAR DISSECTING BLUNT SPATULA ELECTRODE, 5MM X 36CM
• Common Device Name: DISSECTING ELECTRODE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 14679939
• Report Number: 9610617-2022-00093
• Device Sequence Number: 11966636
• Product Code: GEI
• UDI-Device Identifier: 04048551072394
• UDI-Public: 4048551072394
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K944796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26775UE
• Device Catalogue Number: 26775UE
• Device Lot Number: YP02
• 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: 05/25/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2020
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Sex: Unknown