MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BI-POLAR ELECTRODE

Model Number 011160-10

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 06/21/2023

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that the electrode loop broke inside patient mid procedure during turp.The broken part was fully recovered as doctor had to x-ray the patient.

Manufacturer Narrative

The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

The product 27040db was returned to the manufacturer for investigation, while the 011160-10 was discarded by the end user.The investigation was completed on october 13, 2023.The analysis of 27040db revealed the presence of corrosion traces on the entire surface, particularly around the catch for the sling, as well as deformation at the distal end of the shaft.Similar cases involving the 011160-10 indicated that the cutting electrode was subjected to excessive force during application, and it is likely that this was the case here as well.For the 27040db, it was determined that the working element had been incorrectly reprocessed, leading to corrosion throughout the article and deformation at the distal end, both of which resulted from use mechanical damage.The instructions for use (ifu) 97000160 v10.3/01/2019 already contain a caution regarding not overloading the device.It is concluded that the event did not and might not lead to death or serious deterioration in the state of health.No serious public health threat reported.No death or unanticipated serious deterioration in state of health reported.Consequently, the reported issue does not fulfil the criteria of a serious incident ,therefore this case is not reportable.Internal karl storz reference number: (b)(4).

• Brand Name: BI-POLAR ELECTRODE
• Type of Device: BI-POLAR ELECTRODE
• 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: 17279705
• MDR Text Key: 318645775
• Report Number: 9610617-2023-00154
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011160-10
• Device Catalogue Number: 011160-10
• Device Lot Number: 844678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other