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 Problems Break (1069); Thermal Decomposition of Device (1071)

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 reported issue was confirmed.The electrode's cutting loop was found to be dislodged from its housing shaft; however, the dislodged piece was not returned with the electrode.It was noted that there was temperature damage to the remaining cutting loop.The plastic was found melted and black residue was observed.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 off during middle of resection prostate transurethral procedure.Per report, the nurse stated that a filament broke off while the loop was being used.The filament was removed via irrigation by the surgeon.X-ray was not utilized to confirm because the surgeon did not think it was needed.The procedure was completed by using another loop.Karl storz generator was used.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: 17424993
• MDR Text Key: 320046907
• Report Number: 9610617-2023-00194
• 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: 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: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 77 KG