MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, 26 FR.

Model Number 26050G

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2023

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 resection loop broke at the tip during the surgical procedure (bladder rtu) and was removed as soon as realized the incident with patient.It was furthermore confirmed that a medical intervention was required.

Manufacturer Narrative

The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

Result of investigation: according to customer information, the item is 26050g with lot oo03.The received event description states that the resection loop broke at the tip during a surgical procedure (bladder rtu), and was removed as soon as realised the incident with patient.The procedure was completed with a replacement item.The defective item was not returned to the manufacturer.Without the actual involved product, a definite root cause cannot be determined.Only potential causes for the defect can be determined based on similar complaints and customer information.It is possible that the life cycle of 30 reprocessing cycles after production had already been reached.Another possibility could have been a too high voltage.The ifu describes a maximum peak voltage of 3.0 kvp.Applications with device settings above 3.0 kvp can damage the instrument.Another potential cause that could have led to the reported damage could be a mechanical overload.The corresponding instructions for use include the follow safety-relevant information: "warning: risk of injury: overloading the instrument by exerting too much force may cause the medical device to break, bend, and malfunction, and consequently injure the patient or user.Do not overload the instruments.Do not bend bent instruments back to their original positions." "caution: when used together with hf devices, hf/vaporcut electrodes in combination with standard resectoscopes are intended for a recurring peak voltage of max.3.0 kvp and can be used in the standard cutting and coagulation modes.Applications with device settings above 3.0 kvp can damage the instrument" "warning: risk of injury: incorrectly assembled and damaged instruments can lead to injuries to the patient.Instruments and all of the accessories used in combination with them must be checked immediately before and after every use to ensure that they are complete, free from damage, and in full working order and have no unintentional rough surfaces, sharp corners, burred edges or projecting parts.Care must be taken not to leave missing or broken-off components inside the patient." the event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CUTTING LOOP, 26 FR.
• Type of Device: CUTTING LOOP
• 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: 18713951
• MDR Text Key: 335526396
• Report Number: 9610617-2024-00040
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K882270
• 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: 05/28/2024

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 Model Number: 26050G
• Device Catalogue Number: 26050G
• Device Lot Number: OO03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 04/25/2024; 05/23/2024
• Supplement Dates FDA Received: 05/03/2024; 05/28/2024
• Was Device Evaluated by Manufacturer?: No
• 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