MAUDE Adverse Event Report: KARL STORZ SE & CO. KG VIDEO URETERO-RENOSCOPE FLEX-XC1

Model Number 091271-01

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 03/29/2024

Event Type  Injury  

Manufacturer Narrative

The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).

Event Description

It was reported that during a cysto ureteroscopy on (b)(6) 2024, the doctor allegedly stated that the distal tip of the scope that used in the procedure was being sharp and caused damage to the patient's ureteral linning.Nevertheless, they were able to complete the procedure using the same scope without any delay.According to the doctor, patient was given stent analgesics for the pain after the procedure, and seems to be doing better now.

• Brand Name: VIDEO URETERO-RENOSCOPE FLEX-XC1
• Type of Device: VIDEO URETERO-RENOSCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 19154757
• MDR Text Key: 340740089
• Report Number: 9610617-2024-00101
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551428016
• UDI-Public: 4048551428016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2024

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
• Device Operator: Health Professional
• Device Model Number: 091271-01
• Device Catalogue Number: 091271-01
• Device Lot Number: 500082023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/22/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 60 KG