MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEXIBLE URETEROSCOPE 7.5FR X 67.5CM, CHNL:3.6FR

Model Number 11278AUK1

Device Problem No Apparent Adverse Event (3189)

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

Event Date 09/30/2021

Event Type  malfunction  

Event Description

Per initial information received from the customer: during a ureteroscopy with laser procedure the surgeon noticed a small fiber material in the patient's bladder; they removed it and kept it for evaluation.No patient was harmed during the procedure.They are not sure if the fiber came from the scope or the laser fiber.Additional information obtained from the customer: the procedure was a right holmium laser lithotripsy with ureteral stent placement ureteroscopy with laser on (b)(6) 2021.Upon dilating the ureter and inserting the flexible scope over a zipwire the surgeon noted the debris.The scope was removed and a disposable scope was inserted and used for the remainder of the procedure.The debris was then able to be removed with the use of a 1.9 french 0 tip nitinol basket.

Manufacturer Narrative

Device was returned for evaluation.Per the manufacturer's evaluation findings: unable to confirm a defect with the light fibers.Scrapes and debris in the working channel.The lightguides are intact, however, there are some visible voids in the epoxy and some of the fibers appear to protrude from the distal face; could not confirm if the fibers are loose or broken off.Although the lightguides appear to be raised from the distal face, there were no signs of loose fibers large enough to have been visible inside the patient's bladder.Additional findings: chipped distal ceramic sleeve.External puncture in the angle cover 50mm from distal tip, leaks, and debris on the light taper threads.

• Brand Name: FLEXIBLE URETEROSCOPE 7.5FR X 67.5CM, CHNL:3.6FR
• Type of Device: FLEXIBLE 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 90245-5017 ; 4242188738
• MDR Report Key: 14337317
• MDR Text Key: 299877791
• Report Number: 1221826-2022-00072
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2022

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: 11278AUK1
• Device Catalogue Number: 11278AUK1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 83 KG