MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR ELECTRODE; BIPOLAR ELECTRODE LOOP

Model Number 011165-10

Device Problem Material Fragmentation (1261)

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

Event Date 09/03/2020

Event Type  malfunction  

Event Description

It was reported that the surgeon was preforming a turb (transurethral resection of the bladder) and the bipolar loop broke away from the electrode body during cutting.The broken piece was retrieved after the procedure and the patient was not injured.Cutting was on effect 2 and coagulation was on effect 4.Karl storz autocon generator and karl storz bipolar cautery cord were being used.

Manufacturer Narrative

The previous reportability decision for this event was reversed based on a retrospective review.This event was re-opened after being carefully identified as reportable.Pmi is not required due to kst reviewing and signing the dq.Mdr was submitted to the fda and copy is attached.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: BIPOLAR ELECTRODE
• Type of Device: BIPOLAR ELECTRODE LOOP
• 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: 17381439
• MDR Text Key: 319761025
• Report Number: 9610617-2023-00178
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• 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: 823150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2020
• 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