MAUDE Adverse Event Report: KARL STORZ ENDOVISION URETERO-RENO-FIBERSCOPE FLEX-X²; FLEX-X² SCOPE

Model Number	R11278AUK1
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We evaluated the subject flexible scope and we found multiple cuts and tooling/grab marks throughout the length of the angle cover.The damage begins at the distal thread wrap area and continues back to the proximal thread wrap.It appears this is damage caused by instruments used during the procedure.The distal head weld had completely separated on one side and partially separated on the other.This type of damage would take excessive force.The flexible ureteroscope has been in use for approximately 5 months.
Event or Problem Description
During a ureteroscopy procedure the distal wrap of the scope came apart inside the patient's bladder.The broken piece was retrieved and the procedure was completed with no impact on the patient.

• Brand Name: URETERO-RENO-FIBERSCOPE FLEX-X²
• Common Device Name: FLEX-X² SCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• MDR Report Key: 8313098
• Report Number: 1221826-2019-00013
• Device Sequence Number: 19326163
• Product Code: FGB
• UDI-Device Identifier: 04048551226438
• UDI-Public: 4048551226438
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K982905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2019

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
• Operator of Device: Health Professional
• Device Model Number: R11278AUK1
• Device Catalogue Number: R11278AUK1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 87