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

Model Number	11278AU1
Medical Device Problem Codes	Material Fragmentation (1261); Improper or Incorrect Procedure or Method (2017); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1221826-2022-00067
• Device Sequence Number: 17464210
• Product Code: FGB
• UDI-Device Identifier: 04048551226438
• UDI-Public: 04048551226438
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K982905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 11278AU1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown