MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 61873 ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, REUSABLE; CUTTING LOOP, BIPOLAR

Model Number 26040GP

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 09/27/2023

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 upper part of the cutting electrode broke during cutting.The hf generator was set as usual.Due to the reason that a trophyscope to campo had to be used/ inserted to recover the broken parts, an additional medical intervention was required, and the surgery was prolonged.Exact amount of prolongation is not known currently.

Manufacturer Narrative

As the device in question was not returned by the customer, an investigation on the product itself could not be performed.However, the available information has been reviewed.The investigation was completed on 2023-12-12.Based on the available information, the failure description and our experience, we suspect a mechanical overload of the cutting loop which led to the reported breakage.Due to the fact, that the product has not been sent back, a final determination of the root cause is not possible.There is no indication for a material-, manufacturing- or design-related failure.The root cause of the reported issue can most likely be traced back to a usage-related failure.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

As the date of this report the affected device was requested for further investigation, at least three times.Device will not be returned to manufacturer.Investigation is pending.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: 61873 ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, REUSABLE
• Type of Device: CUTTING LOOP, BIPOLAR
• 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: 17931521
• MDR Text Key: 325621910
• Report Number: 9610617-2023-00288
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K221893
• 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: 12/20/2023

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: 26040GP
• Device Catalogue Number: 26040GP
• Device Lot Number: NO08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 11/16/2023; 12/12/2023
• Supplement Dates FDA Received: 12/06/2023; 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention