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

Model Number 27040EB

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 10/20/2020

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 electrode plug of the bipolar high-frequency cable was melted and burned off.The proximal part of the electrode was damaged and can not fully plug in the working element.The returned bipolar high-frequency cable was not karl storz's product.The potential root cause is either the electrode was not fully inserted or there was residual moisture in the connector - both that could lead to increased contact resistance and thus to heat generation when current flows.The event is filed under internal (b)(6) complaint id (b)(4).

Event Description

It was reported that there was event with a "working element, bipolar." according to the information received, "the problem is that a combination or 1 item makes the cable burn through, smoke came out of the gender of patient." further information is not available.

• Brand Name: WORKING ELEMENT, BIPOLAR
• Type of Device: WORKING ELEMENT, 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: 17418281
• MDR Text Key: 320037193
• Report Number: 9610617-2023-00633
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 07/24/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 27040EB
• Device Catalogue Number: 27040EB
• Device Lot Number: RR08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2018
• 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
• Treatment: 27040BL1- COAGULATION ELECTRODE, BIPOLAR; 27040GP1 CUTTING LOOP, BIPOLAR, 24/26 FR.; 27040GP1 CUTTING LOOP, BIPOLAR, 24/26 FR.; 27040NB- VAPORIZATION ELECTRODE, 24/26 FR.; 27224A- CONE WITH HOSE PART, FOR 27224; UFOREIGN-BRAND- KABLE- THIRD-PARTY PRODUCT
• Patient Outcome(s): Other