MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BUGBEE CORD; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGI

Model Number 2770

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2023

Event Type  malfunction  

Event Description

It was reported that the bugbee cord had a flame coming off during the cysto procedure.The surgeon request bugbee to be used so it was hooked up with the bovie and switched to using glycine irrigation.After using the bugbee for a few minutes, the technician noticed a flame coming off the bugbee cord at the site of the bovie port.The flame was put out and the bovie machine was turned off.There was no abnormality observed with the device prior to procedure.Valley lab force fx 4489 was used together with the cord.There was no report of injury to patient or anyone in the operating room.

Manufacturer Narrative

Several attempts were performed to obtain additional information and product for evaluation; however, the reporter has not provided more information or whether the suspected product would be available to return for evaluation.Once the evaluation is completed or new information is received, a supplemental report will be submitted ot the fda.The reported complaint will be tracked and trended.Please refer to the report from health facility: mw5145583.The event is filed under internal karl storz complaint id: 974659.

Manufacturer Narrative

The reported device was returned for evaluation.Visual and physical inspections were performed.Examination of the item reveals no damage other than signs of use (bends, etc.).According to the customer's description, the plug side of the cable has started to burn, but this was not sent in and therefore cannot be examined.The electrode was used in conjunction with a valley lab force fx4489.It could be assumed that there was a fault in the cable, which subsequently led to a fire.Per instruction for use, "ensure that the electrodes are in good working order before each use.If there are any signs of damage on the insulation, the product not be used under any circumstances.When hf current is used, the electrode tips must never come into contact with other uninsulated instruments/objects in the operating field.These instruments are intended for a recurring peak voltage of max.3.0 kvp and are only suitable for the short-term coagulation of small hemorrhages.Danger of overloading.Applying or exerting too much force on the instrument may lead to damage to the instrument or accessories, impairment of functioning and/or injury to the patient.Damaged or bent instruments must not be bent back into shape.Risk of injury and breakage if these instructions are disregarded." the device history records have been checked and found to be according to the specification.This complaint will continue to be tracked and trended.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: BUGBEE CORD
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGI
• 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 ; 4242188247
• MDR Report Key: 17951610
• MDR Text Key: 325895499
• Report Number: 9610617-2023-00291
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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: 2770
• Device Catalogue Number: 2770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 03/20/2024
• 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
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 74 KG