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

Model Number 27040GP1

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 07/11/2023

Event Type  Injury  

Event Description

It was reported that a customer reported to the italian authority that a resection loop broke during the procedure.The broken part migrated from the bladder in the abdominal cavity.There is no information whether the part was retrieved or not.There is also no information about the patient outcome.Thus, a report is required.

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).

Manufacturer Narrative

The procedure was completed successfully.Diagnostic and later surgical intervention was required to treat another complication that occurred independently of, but concurrently with, the loop problem.The sling fragment was removed in the course with the treatment of the complication, without any difficulty or prolongation of the operation already performed to resolve another complication.No additional/ prolonged hospitalization required.The product was returned on 2023-09-19.The investigation of the product was completed on 2023-10-11.Unfortunately, not the complete instrument was returned, but only a part.The returned part was examined and found to be exposed to an above-average force due to deformation of the loop or the wire.The most probable root cause is that the user caused this wire deformation by scraping with the instrument without pressing the foot switch to release the current.Without the current flow, this caused damage to the instrument.Then, when the foot switch was activated, the deformation and possible damage to the instrument caused a short circuit, which in turn caused thermal damage in the form of high temperature and melting of the insulation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, REUSABLE
• Type of Device: CUTTING LOOP, BIPOLAR, 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: 17759157
• MDR Text Key: 323540044
• Report Number: 9610617-2023-00256
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K061541
• 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
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040GP1
• Device Catalogue Number: 27040GP1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening