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

Model Number 27294AA

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).

Event Description

It was reported that during fifth surgery the vision got lost.It was found that objective lens detached from tip.The procedure abandoned.

• 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
• MDR Report Key: 18060115
• MDR Text Key: 327216009
• Report Number: 2020550-2023-00339
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04048551233825
• UDI-Public: 4048551233825
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2023,11/02/2023

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: 27294AA
• Device Catalogue Number: 27294AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/31/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other