MAUDE Adverse Event Report: KARL STORZ ENDOVISION VIDEO-URETERO-RENOSCOPE FLEX XC; VIDEO URETEROSCOPE

Model Number 11278VSUEK

Device Problems Thermal Decomposition of Device (1071); Material Deformation (2976); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2021

Event Type  Injury  

Manufacturer Narrative

The receipt and evaluation of affected device is pending.

Event Description

Per the customer, the video ureteroscope's bending rubber split apart during a case, and the whole scope became stuck inside of patient.The surgeon used a laser to incise mucosa on the inside of patient's ureter in order to remove the video ureteroscope, and placed a stent, which will be left in for two weeks.

Manufacturer Narrative

As per request from the fda during a recent audit, submitting this mdr supplement in order to correct the type of reportable event to 'serious injury'.

Manufacturer Narrative

The manufacturer's evaluation findings are as follows: thermal damage to angle cover and vertebrae system 9-14mm from distal tip.Angle cover is elongated and melted 9-14mm from distal tip, leaks.Loss of deflection due to melted deflection wire, 270° up/285° down.Scrapes on proximal thread wrap from external laser.Thermal damage to working channel exterior surface, not leaking.Thermal melt marks on external channel braid.Broken light fiber due to thermal melting.Crush on proximal shaft 487mm from distal tip.Dents on distal tip.Due to the extensive thermal damage on the distal section, we were unable to determine the cause for the angle cover failure.However, per previous testing of the same model video ureteroscope performed by the manufacturer, it was concluded that sterilization by the end user using the sterrad system without the vent cap properly in place can cause a loose angle cover, which is then susceptible to bunching or rolling and could cause the scope to become stuck in the patient.Our ifu contains warnings in regards to visual inspection of the state of the product prior to use.

• Brand Name: VIDEO-URETERO-RENOSCOPE FLEX XC
• 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 ; 13803 n. promenade blvd.; stafford, TX 77477
• MDR Report Key: 13192661
• MDR Text Key: 288171850
• Report Number: 1221826-2021-00088
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551417003
• UDI-Public: 4048551417003
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2022

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: 11278VSUEK
• Device Catalogue Number: 11278VSUEK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 12/01/2021; 12/01/2021
• Supplement Dates FDA Received: 01/11/2022; 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• 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: 56 YR
• Patient Sex: Male