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

Model Number 27040GP1-S

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

Product has been discarded by the facility.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.The event is filed under internal karl storz complaint id (b)(4).

Event Description

According to the information we received, the electrode item 27040gp1-s bipolar cutting loop was missing from the electrode.The loop was found inside the patient's bladder, it was retrieved and the turp procedure completed with no harm to the patient.

Manufacturer Narrative

Kst/mfr.Has provided the complaint product investigation plan and report which is based on the non return of product.Report conclusion root cause is according to the customer, the cutting loop was pulled out in the distal area.The reason for this could be, for example, excessive tensile force on the loop without having activated the hf current.However, since the article was not sent in for examination, no more precise statement can be made on this.The ifu points out the correct handling.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: BIPOLAR ELECTRODE 24/26 FR
• Type of Device: CUTTING LOOP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, deu, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, deu, ; GM
• Manufacturer Contact: anja fair ; 2151 east grand avenue; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 16768903
• MDR Text Key: 313578411
• Report Number: 9610617-2023-00083
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551393482
• UDI-Public: 4048551393482
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

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: 27040GP1-S
• Device Catalogue Number: 27040GP1-S
• Device Lot Number: 37KB3555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male