MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CALCULASE III FIBER 230 ¿M REUSABLE

Model Number UL007

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2024

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that a fragment of fiber broke off in patient during procedure after second use of fiber.

• Brand Name: CALCULASE III FIBER 230 ¿M REUSABLE
• Type of Device: CALCULASE III FIBER 230 ¿M REUSABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 18778948
• MDR Text Key: 336225450
• Report Number: 2020550-2024-00047
• Device Sequence Number: 1
• Product Code: GBL
• Combination Product (y/n): N
• Reporter Country Code: HR
• 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: 02/23/2024,02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UL007
• Device Catalogue Number: UL007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/22/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other