MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. BI-POLAR ELECTRODE

Model Number 011165-10

Device Problem Material Fragmentation (1261)

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

Event Date 09/29/2022

Event Type  malfunction  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).

Event Description

The event occurred in canada.It was reported that the loop of the bipolar electrode broke off inside the patient during a transurethral resection of a bladder tumor but could be retrieved.No harm to the patient, the user or third reported.

Manufacturer Narrative

On 12/15/2022, ksec received inquiry from health canada requesting the additional information below: the investigation is still ongoing.We will provide you this information.1 similar complaint and or injuries reported with this device in canada in 2020 and 2 reported internationally in 2021.As the investigation is ongoing, the root cause can not be established.1/12/2023: investigation is being carried out by manufacturer kst.New anticipated date for the final report will be end of april.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

Due to the heavy bending, it is assumed that the electrode got exposed to excessive force during the application.The force needed to create this bending is not required during application as intended.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: BI-POLAR ELECTRODE
• Type of Device: BI-POLAR ELECTRODE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e grand ave; el segundo CA 90245 5017
• Manufacturer (Section G): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e grand ave; el segundo CA 90245 5017
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 16040231
• MDR Text Key: 308149074
• Report Number: 1221826-2022-00342
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 08/14/2023

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: 011165-10
• Device Catalogue Number: 011165-10
• Device Lot Number: 837970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 12/15/2022; 07/24/2023
• Supplement Dates FDA Received: 01/12/2023; 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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