MAUDE Adverse Event Report: KARL STORZ ENDOVISION VIDEO URETEROSCOPE, 8.5 FR. X 700MM

Model Number 11278VSEK

Device Problem Optical Problem (3001)

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

Event Date 06/14/2023

Event Type  malfunction  

Event Description

It was reported that, during a urethroscopy/cystoscopy and intracorporeal laser lithotripsy on (b)(6) 2023 (on a 10 year old canine, male castrated, mastiff, about 155 lbs), the scope stopped working during the fragmentation of the second urolith, and thus a urethrotomy was needed to remove the residual stone.A back-up flex-x2s scope was used for retrieval of a stone fragment since the surgeon was not able to scope the dog after needing to abort lithotripsy to confirm that all fragments were removed.The canine had to recover in the icu due to surgery ending after hours.He was transferred to fluids wards the following morning where he remained hospitalized for four more days than anticipated to ensure proper healing of the urethra and prevent urethral strictures resulting from the surgical conversion.The total delay to the procedure was about 4 hours.

Manufacturer Narrative

The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal case (b)(4).

Manufacturer Narrative

Per evaluation findings by the manufacturer: no image.No light output.Puncture in the channel with a leak.Leaking at the seam of the ccu cable.Fluid invasion in the housing.This complaint was escalated due to a reported malfunction while in use resulting in a prolonged procedure.Product evaluation confirmed the image and light output failure noted in the complaint.Additional investigation has determined that this failure was attributed to fluid invasion which caused damage to the electronic components.Fluid ingress was caused by a defect in the housing material.

• Brand Name: VIDEO URETEROSCOPE, 8.5 FR. X 700MM
• Type of Device: VIDEO URETEROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 17326392
• MDR Text Key: 319204291
• Report Number: 1221826-2023-00161
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551417089
• UDI-Public: 4048551417089
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 11278VSEK
• Device Catalogue Number: 11278VSEK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 10/18/2023
• 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 Outcome(s): Other