MAUDE Adverse Event Report: KARL STORZ SE & CO. KG POWER LED SAPHIRA, OPAL1 PDD; LED LIGHT SOURCE

Model Number TL410US

Device Problem Fracture (1260)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/19/2023

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 before a case on dec-19-2023, an employee was cut handling the device (the front of the device was broken).There was no patient involvement, and no further information was provided about the injury of the employee.

• Brand Name: POWER LED SAPHIRA, OPAL1 PDD
• Type of Device: LED LIGHT SOURCE
• 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: 18488837
• MDR Text Key: 332601492
• Report Number: 9610617-2024-00001
• Device Sequence Number: 1
• Product Code: OAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TL410US
• Device Catalogue Number: TL410US
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/19/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other