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

Model Number 27040EB

Device Problem Smoking (1585)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2020

Event Type  malfunction  

Event Description

It was reported that there was event with a working element.According to the information received, burns occurred on our instruments during an endoscopic procedure in the uroresection.Our autocon iii 400 was used with the hf cable uh801 and the working element 27040eb.The current burned a hole in the cable connector while it was connected to the working element.This severely damaged the working element.The burn was noticed by the user when the corresponding odour developed.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 12.According to the investigation results and the information received the failure was caused by sorrosion and the locking mechanism of the electrode was found to be rough running because of that.The most probable root cause is a not correct locked electrode which loosened over time and caused the durrent leakage.There is no indication for a material or manufacturing related issue.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: WORKING ELEMENT, BIPOLAR
• Type of Device: WORKING ELEMENT
• 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: 16974009
• MDR Text Key: 315759948
• Report Number: 9610617-2023-00632
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/22/2023

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: 27040EB
• Device Catalogue Number: 27040EB
• Device Lot Number: NQ10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1