MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATING ELECTRODE

Model Number 27033ER

Device Problem Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/24/2023

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 the loop burned inside the patient and broke apart causing an injury to the patient.This caused a critical situation.Additional information has been requested regarding the incident.

Manufacturer Narrative

The reported device was not returned for evaluation.Based on the examination of the data, it is likely that the user concealed the article 27033er when assembling the components, so that the distance between the coagulation electrode and the mounted miniature optics as well as the resectoscope shaft was no longer given.By using the components, the small distance most likely caused a short circuit, which led to thermal damage to the coagulation electrode and most likely caused it to come loose.As the short circuit may have caused an electric arc to form which could damage the optics, this release of energy could have broken the ceramic beak on the resectoscope shaft or caused burn marks.However, the main reason for the consequential error is the failure to maintain the distances due to a bent coagulation electrode, which was probably bent when mounted on the working element due to improper force.This complaint will continue to be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: COAGULATING ELECTRODE
• Type of Device: COAGULATING ELECTRODE
• 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 ; 4242188247
• MDR Report Key: 17906576
• MDR Text Key: 325305581
• Report Number: 9610617-2023-00280
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04048551274330
• UDI-Public: 4048551274330
• Combination Product (y/n): N
• Reporter Country Code: IZ
• PMA/PMN Number: K961702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27033ER
• Device Catalogue Number: 27033ER
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 27033AA-MINIATURE TELESCOPE 0°,1.2 MM, 20 CM; 27033E - WORKING ELEMENT; 27033R-RESECTOSCOPE SHEATH, 9 FR.; 277-UNIPOLAR HIGH FREQUENCY CORD, 300 CM
• Patient Outcome(s): Other