MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR HIGH FREQUENCY CORD, 400 CM; CABLE OR SWITH FOR ELECTROSURGICAL UNIT

Model Number 27176LEB

Device Problem Arcing of Electrodes (2289)

Patient Problem Burn(s) (1757)

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that an intrauterine endometrial polypectomy was performed via bipolar resection.Toward the end of the surgery, a loud sound was heard from the hf device and at the same time electrical cracking sounds were heard from the bipolar cables connected to the working element.The doctor's hand got injured because the arc was formed.When she saw the injury, she passed out.The surgery was canceled, no harm to the patient.

• Brand Name: BIPOLAR HIGH FREQUENCY CORD, 400 CM
• Type of Device: CABLE OR SWITH FOR ELECTROSURGICAL UNIT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 16471313
• MDR Text Key: 310553561
• Report Number: 2020550-2023-00049
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04048551081334
• UDI-Public: 4048551081334
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2023,03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27176LEB
• Device Catalogue Number: 27176LEB
• Device Lot Number: ZX-ZS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZC_200948129: MATERIAL-NO.: 27040GP1 (LOT: YS28).; ZC_200948130: MATERIAL-NO.: 27040GP1 (LOT: YS28).; ZC_200948171: MATERIAL-NO.: 27040EB (LOT: OR06).; ZC_200948537: MATERIAL-NO.: 20013831 (SN: N/A).; ZC_200948538: MATERIAL-NO.: 20535220-115 ( SN:(B)(4)).
• Patient Outcome(s): Other