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

Model Number 11278AU1

Device Problems Material Fragmentation (1261); Improper or Incorrect Procedure or Method (2017); Material Integrity Problem (2978)

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

Event Date 01/07/2022

Event Type  Injury  

Event Description

Per copy of mdr #mw5106633 received via mail from the fda: while using flexible ureteroscope during a ureteroscopy doctor visualized a foreign object.It was retrieved and was blue in color and observed by staff.It was determined to be part of scope.No patient harm detected.

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.

• 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: 14339104
• MDR Text Key: 294675139
• Report Number: 1221826-2022-00067
• 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: 05/09/2022

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: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other