MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 6°, 18 FR.

Model Number 27294AA

Device Problems Material Fragmentation (1261); Optical Problem (3001)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2024

Event Type  Injury  

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).

Event Description

It was reported that "during pcnl sudden loss of vision occurred and all lens of the telescope fall out." further received information indicates that the procedure was prolonged by more than 60 minutes and could not be completed successfully.The information also indicate that the procedure had to be postponed by 2 days and additional/prolonged hospitalization was required.

• Brand Name: HOPKINS TELESCOPE 6°, 18 FR.
• Type of Device: HOPKINS TELESCOPE
• 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
• MDR Report Key: 19105175
• MDR Text Key: 340150698
• Report Number: 9610617-2024-00106
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04048551233825
• UDI-Public: 4048551233825
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K943176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2024

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: 27294AA
• Device Catalogue Number: 27294AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization