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

Model Number 27040GP1

Device Problem Flare or Flash (2942)

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

Event Date 07/03/2020

Event Type  Injury  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 6.The event is filed under internal karl storz complaint id (b)(4).The device in question was sent to the manufacturing site in germany on 7th october 2020 for investigation.The hf-bipolar cable was broken and burned at the connection area.The inner wire was also broken and melted.If inner wire had previous damage such as kink or broken, it could lead to increased contact resistance and thus to heat generation when hf current flows.Flame appears at the handle was the result of bursting of cable cover when heat and pressure increased.The damaged on inner wire could be caused by pulling or bending actions.

Event Description

It was reported that there was event with a "cutting loop".According to the information received: normal use for 3/4 of the operation and then a flame appears at the handle.Operation stopped immediatly.Further information is not available.

• Brand Name: CUTTING LOOP, BIPOLAR, 24/26 FR.
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, B
• 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: 17225774
• MDR Text Key: 318105323
• Report Number: 9610617-2023-00855
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2023

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
• Device Operator: Health Professional
• Device Model Number: 27040GP1
• Device Catalogue Number: 27040GP1
• Device Lot Number: SS19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2017
• 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: 27040DB WORKING ELEMENT, BIPOLAR; 27176LEB BIPOLAR HIGH FREQUENCY CORD, 400 CM
• Patient Outcome(s): Other