MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, REUSABLE; CUTTING LOOP, BIPOLAR, 24/26 FR.

Model Number 27040GP1

Device Problem Arcing of Electrodes (2289)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2023

Event Type  malfunction  

Event Description

During a bipolar endoscopic urological surgery procedure, there was an electric arc at the power cable (erbe generator).Stopping surgery to change the entire device.No patient consequences.

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id (b)(4).

Manufacturer Narrative

Correction is made in section d10.The second material-number "6040nb" is now corrected to 26040nb coagulating electrode, bipolar (lot: xt01).The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

The returned products were inspected by a designated karl storz employee.The products showed signs of use and some damages.However, the signs of use and damages found do not match the error description from the customer and it is concluded that these are not the cause for the described error "electric arc at the power cable (erbe generator)".The involved power cable got lost before it could be returned to the investigation site and could therefore not be inspected.Based on the inspection of the other products and the received error description, it is concluded that the power cable was the most likely cause for the error.Since no physical inspection of the cable could be carried out, and it is not clear if it is a karl storz product, a deeper investigation is not possible.The event is filed under internal karl storz complaint id: (b)(4).

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

This report is to correct section d9 to reflect the accurate date of return for all of the returned products.Also another involved product 39301h plastic container, 513x238x63mm was returned october 9, 2023.The investigation is currently ongoing and the involved power cable has also been requested for investigation but not yet returned.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, REUSABLE
• Type of Device: CUTTING LOOP, BIPOLAR, 24/26 FR.
• 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: 17770108
• MDR Text Key: 323959219
• Report Number: 9610617-2023-00260
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K061541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040GP1
• Device Catalogue Number: 27040GP1
• Device Lot Number: SN12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 09/21/2023; 10/12/2023; 10/09/2023; 12/18/2023
• Supplement Dates FDA Received: 09/21/2023; 10/18/2023; 11/13/2023; 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2022
• 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
• Treatment: 26040NB COAGULATING ELECTRODE, BIPOLAR (LOT: XT01; 26040OC STANDARD OBTURATOR (LOT: ED); 27040BL1 COAGULATION ELECTRODE, BIPOLAR LOT: UP01; 27040DB WORKING ELEMENT, BIPOLAR (LOT: SN11); 27050SL RESECTOSCOPE SHEATH, 26 FR. (LOT: PT01); 27050XA INNER SHEATH FOR 27050 SL (LOT: PT06); 6040NB COAGULATING ELECTRODE, BIPOLAR (LOT: XT01); CORRECT MATERIAL-NUMBER NOT YET KNOWN; CORRECT MATERIAL-NUMBER NOT YET KNOWN
• Patient Outcome(s): Disability