MAUDE Adverse Event Report: KARL STORZ SE & CO. KG URETERO-RENO-FIBERSCOPE FLEX-X2S

Model Number 11278A1

Device Problem Material Perforation (2205)

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

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0074 corrective action 6.Upon evaluation the device was found to be damaged near the tip.The appearance of the fracture is burned.A leakage was confirmed through water bath.Furthermore it was found that a piece of the ceramic tip was broke off.As the device was used in conjunction with a laser fiber application it is suspected that the device was damaged by the laser.Due to the damages seen the root cause most likely is user related and caused by thermal damage.No indication for a material or manufacturing related issue was found during investigation.The event is filed under internal karl storz complaint id (b)(4).

Event Description

During the lithotrissia with iaser fiber, the breakage of the external sheath of the uretherenenoscope (urs) will occur.This entailed the infiltration of washing liquid (physiological solution, iodinated centrast agent and urine), within the optical channels of the instrument with consequently difficult, almost impossible vision of the operative field and consequent forced interruption of the lithotripsy procedure not yet completed.Lt is also specified that the tip of the fiber iaser was located outside the instrument at the time of the aforementioned breakage.They stopped the first procedure.They did a new procedure so prolongation of the hospitalization.

• Brand Name: URETERO-RENO-FIBERSCOPE FLEX-X2S
• Type of Device: URETERO-RENO-FIBERSCOPE FLEX-X2S
• 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
• MDR Report Key: 17079691
• MDR Text Key: 316695459
• Report Number: 9610617-2023-00672
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K982905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2023

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
• Device Operator: Health Professional
• Device Model Number: 11278A1
• Device Catalogue Number: 11278A1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention