MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR CUTTING LOOP; CUTTING LOOP, BIPOLAR, 0.30MM, 24/26 FR.

Model Number 27040GP130-S

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

The previous reportability decision for this event was reversed based on a retrospective review.The reported product was returned and evaluation was performed.The cutting loop was confirmed to be broken.There was sign of temperature damages to cutting loop and prongs.The plastic insulation was also found melted.The reported issue is tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that the bipolar cutting loop broke during blue light transurethral resection of bladder tumor surgery.The loop broke apart while the surgeon was cauterizing toward the end of the procedure.The scope was retracted and piece of the loop was found missing.The surgeon attempted to locate the broken piece and found it in the patient's bladder.After a couple of attempts, the broken piece was retrieved successfully with a grasper.It was confirmed by the surgeon that all the pieces were there and nothing else was found in patient's bladder.Another loop was used to complete the procedure.There was no report of injury to the patient.

• Brand Name: BIPOLAR CUTTING LOOP
• Type of Device: CUTTING LOOP, BIPOLAR, 0.30MM, 24/26 FR.
• 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: 17424946
• MDR Text Key: 320048406
• Report Number: 9610617-2023-00189
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040GP130-S
• Device Catalogue Number: 27040GP130-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2021
• 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