MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE, UNIPOLAR, POINTED; ENDOSCOPIC ELECTROSURGICAL ELECTRODE

Model Number 011111-10

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 12/19/2023

Event Type  malfunction  

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 while conducting the transurethral incision of the bladder neck, the surgeon noticed the collins knife tip had split.Surgeon informed scrub nurse to exchange the collins knife and proceeded with the operation.

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

Upon analysis during manufacturing, it was discovered that the cutting wire of the returned device had separated at the tip, with molten areas evident on both sides of the separation.Although the electrode tip showed melting on both sides of the separation without any abrasion, overheating is likely the cause.This overheating could have occurred due to various factors, such as accidental contact with another instrument causing a shortcut, prolonged operation without adequate cooling time, or selecting too high a voltage on the hf generator.It's important to note that the corresponding instruction for use (ifu 97000160_v 10.4) already includes a voltage limitation to prevent thermal overload.Furthermore, the ifu emphasizes that using device settings exceeding the specified values can lead to damage to the instrument.There have been no reports of patient harm or injury associated with this issue.The broken part was retrieved without any harm to the patient, therefore this case is non-reportable in united kingdom.Internal karl storz reference number: (b)(4).

• Brand Name: ELECTRODE, UNIPOLAR, POINTED
• Type of Device: ENDOSCOPIC ELECTROSURGICAL 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: 18519519
• MDR Text Key: 332941550
• Report Number: 9610617-2024-00010
• 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: 05/14/2024

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: 011111-10
• Device Catalogue Number: 011111-10
• Device Lot Number: 836146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 01/31/2024; 05/10/2024
• Supplement Dates FDA Received: 02/14/2024; 05/14/2024
• 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