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

Model Number 27040DB

Device Problem Excessive Heating (4030)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that there was event with a working element.According to the information received, the connections have burned.Additional information is not available.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 12.Investigation revealed a burned adapter.This is caused by not fitting contacts of the connections or not completely dries surfaces after reprocessing.Warnings are in cluded in the ifu, the root cause is most probably usage-related.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: 16974010
• MDR Text Key: 315759966
• Report Number: 9610617-2023-00631
• 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,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: 27040DB
• Device Catalogue Number: 27040DB
• Device Lot Number: OT02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2018
• 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