MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE, BIPOLAR

Model Number 011160-01

Device Problem Melted (1385)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0074 corrective action 6.The hf-generator is defective, most certainly due to overheating.Based on the data from the system information and the last repair of the autocon, an exceeding of the duty cycle limitation by the customer is probable.The autocon showed clear signs of damage with the repeated generation of the error c-21 on 4th of june, which should have resulted in the autocon to be sent to repair.The higher power output in cutting stage due to the defective generator may have led to the destruction of the loop.This damage results in worsening of the incision process in saline-c-cut++ mode and decreased efficiency of saline-coag++.This has damaged the electrodes.The event is filed under internal karl storz complaint id ((b)(4)).

Event Description

It was reported that there was an event with an electrode.According to the provided information, the single use device melted, metal thread broken.For reusable cutting loop: not functioning, thread broken.No further information provided.

• Brand Name: ELECTRODE, BIPOLAR
• Type of Device: ELECTRODE, BIPOLAR
• 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: 17290709
• MDR Text Key: 318760267
• Report Number: 9610617-2023-00833
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011160-01
• Device Catalogue Number: 011160-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 20535220-115 - AUTOCON II 400 SCB, HIGH-END; 27040GP - CUTTING LOOP, BIPOLAR, 24/26 FR.