MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR HIGH FREQUENCY CORD; BIPOLAR HIGH FREQUENCY CORD FOR KARL STORZ GENERATOR UH400U

Model Number UH801

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2023

Event Type  malfunction  

Event Description

It was reported that there was an issue with the product (uh801) bipolar high frequency cord.According to the information received, the generator was not responding.A new restroscope set was opened and the cord plugged in and the engery setting for saline tur was chosen.This the second cord did not harm the patient or the surgeon with any damage to the tissue.The cord plug did burn the second working element, visible to the naked eye.There was not harm to the patient or user.

Manufacturer Narrative

Evaluation/investigation of the product: connector is dicolored and worn from wear and tear.Ifu 97000149 ifu v2.0(10-2017) bipolar hf cable warns "instruments and all of the accessories used in combination with them must be checked immediately before and after every use to ensure that they are complete, free from damage and to make certain that the plug connection maintains good contact.Poor or insufficient contact or damage to the cable insulation and plugs may lead to voltage flashovers.This complaint involves a total of 6 items ((b)(4)) of which (b)(4) are probably the cause of the reported issue.Those two complaints will be reported to the local competent authority mentioning the causal components within the report as involved.There will be no separate report for (b)(4).The malfunction is filed under internal complaint id (b)(4).

• Brand Name: BIPOLAR HIGH FREQUENCY CORD
• Type of Device: BIPOLAR HIGH FREQUENCY CORD FOR KARL STORZ GENERATOR UH400U
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e, grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 16993770
• MDR Text Key: 315855463
• Report Number: 9610617-2023-00102
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04048551388778
• UDI-Public: 4048551388778
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UH801
• Device Catalogue Number: UH801
• Device Lot Number: SO02-40325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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: 27040EBUH80127040EBUH400UUF902-T
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 69 KG