MAUDE Adverse Event Report: KARL STORZ ENDOVISION VIDEO URETERO-RENOSCOPE FLEX-XC; FLEXIBLE VIDEO URETERORENOSCOPE, REUSAB

Model Number	11278VS
Medical Device Problem Codes	Material Invagination (1336); Ejection Problem (4009)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient has previously had ureteric stones and previous surgeries.Pyelogram performed at the start of the case, identified patient had a stricture in the right ureter.(b)(6) 23, flex xc was being used for a primary ureteroscopy to laser a 7mm mid ureteric stone located in the right side ureter.No access sheath was used only a guide wire alongside scope.After the stone was lasered, the surgeon went to remove the scope, however, was unable to be pulled out.Medication was provided to the patient to relax the ureter to assist in dilating enough to remove the scope; however, the intervention was not successful.A decision was made by the clinical team to leave the scope to the patient.The scope was then successfully removed on (b)(6) 23.The scope sheath on the distal end of the scope had bunched together (see images attached).The patient was admitted to icu and is reported fine.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The product was returned for investigation at manufacture and investigation completed on 31 octorber 2023.Upon thorough analysis of the returned endoscope, it was discovered that the angled cover had been improperly handled during its use.The cover had been lifted before insertion into the patient, facilitating the shaft's placement.However, upon removal, the angled cover became dislodged and was unable to be extracted.Additionally, the angled cover lost its original consistency during the operation, obstructing the removal of the sheath from the patient.Due to the prolonged duration of the endoscope within the patient's body (exceeding 3 days), both the sheath and the angled cover sustained further damage.A spot check conducted on october 11, 2023, in the second warehouse focused on evaluating the consistency and fit of the angled cover for various endoscopes.The results indicated that the fit and strength of the angled cover met the required standards for all tested endoscopes.The root cause of observed issues are highly likely attributed to user error.The instruction for use ifu 96136028d_v2.1-09/2022, version bd already contains a caution to check the device for proper functioning before use.Since the second intervention was required to remove the scope, this case is reportable.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: VIDEO URETERO-RENOSCOPE FLEX-XC
• Common Device Name: FLEXIBLE VIDEO URETERORENOSCOPE, REUSAB
• 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 ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 17605209
• Report Number: 1221826-2023-00218
• Device Sequence Number: 14987220
• Product Code: FGB
• UDI-Device Identifier: 04048551344408
• UDI-Public: 4048551344408
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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
• Operator of Device: Health Professional
• Device Model Number: 11278VS
• Device Catalogue Number: 11278VS
• Device Lot Number: 4222703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown