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 Date 11/10/2021

Event Type  malfunction  

Event Description

It was reported that the bipolar cutting loop broke off in the middle of cystourethroscopy procedure.The patient was receiving the cystourethroscopy with irrigation and evacuation of multiple obstructing clots.The broken piece was discovered in the drapes attached to a large clot that was being removed from the patient.Per report, the physician did not utilize grasper because the clot was too big.Another electrode was used to continue with the procedure.The physician confirmed there was no evidence of foreign object remained in patient.Pyelogram was performed as part of the procedure after the discovery of broken piece.There was no report of injury to the patient.

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 detached/dislodged from its housing staff.The broken piece was not returned together with the electrode.There was sign of temperature damages to cutting loop.The distal plastic insulation was found melted and black residue was noted.The reported issue is tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

• 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: 17500665
• MDR Text Key: 320805729
• Report Number: 9610617-2023-00197
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• 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
• Device Lot Number: 37BA2547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2021
• 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
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 67 KG