MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOSCOPIC ELECTROSURGICAL ELECTRODE

Model Number 011161-10

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2024

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).

Event Description

It was reported that during the resection of the fibroid the cutting loop snapped off.The piece fell into patient.X-ray was taken but the piece wasn't found.Due to the potential fragment in situ the case is reportable as a precautionary measure.

Manufacturer Narrative

Additional information is provided in section d9 to reflect that the product was returned for evaluation.The item in question was returned to the manufacturer.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id:(b)(4).

Manufacturer Narrative

During the technical investigation (2024-05-28) of the returned product, the following was found: the frame of the cutting loop is bent to the side.The cutting loop is broken off and missing.The broken surface shows a ductile appearance.As the electrode is bent and the broken surface shows a ductile break, which indicates a break by force, it is most likely that the electrode got exposed to excessive force during application.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE
• Type of Device: ELECTRODE
• 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
• MDR Report Key: 19154522
• MDR Text Key: 340796422
• Report Number: 9610617-2024-00117
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2024

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
• Device Operator: Health Professional
• Device Model Number: 011161-10
• Device Catalogue Number: 011161-10
• Device Lot Number: 842998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other