MAUDE Adverse Event Report: KARL STORZ ENDOVISION, INC. URETERO-RENO-FIBERSCOPE; FLEX-X 2 FLEXIBLE SCOPE

Model Number 11278AU1

Device Problem Insufficient Information (3190)

Patient Problem Rupture (2208)

Event Date 01/10/2022

Event Type  Injury  

Manufacturer Narrative

Product has not been returned for evaluation.Per karl storz representative the facility has been using third party repair companies since april 2020.No serial number was provided by account.

Event Description

Per copy of mdr #mw506891 received via email from the fda: while using flexible ureteroscope the ureter was torn and a ureteral stent has to be placed until tear healed.

• Brand Name: URETERO-RENO-FIBERSCOPE
• Type of Device: FLEX-X 2 FLEXIBLE SCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION, INC.; 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 avenue; el segundo, CA 90245 ; 4242118810
• MDR Report Key: 13824598
• MDR Text Key: 292590478
• Report Number: 1221826-2022-00026
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551226438
• UDI-Public: 04048551226438
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 11278AU1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/19/2022
• 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): Other