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

Model Number 26775UE

Device Problems Material Puncture/Hole (1504); Temperature Problem (3022)

Patient Problem Bowel Burn (1756)

Event Date 04/20/2022

Event Type  Injury  

Manufacturer Narrative

Preliminary results of initial inspection of the product: found a 1mm hole in the insulation.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 294046154
• Report Number: 9610617-2022-00093
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04048551072394
• UDI-Public: 4048551072394
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K944796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability