PKG L11 LED LIGHT SOURCE WITH AIM
Report
- Report Number
- 0002936485-2025-00468
- Event Type
- Malfunction
- Date Received
- May 22, 2025
- Date of Event
- April 24, 2025
- Report Date
- August 11, 2025
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- OWN
- UDI-DI
- 07613327455915
- PMA / PMN Number
- K182160
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
ALLEGED FAILURE: FLICKERS AND TURNS OFF CONFIRMED FAILURE: HARDWARE UPGRADE (NPF) REPLACE CONTACT ESST SPRING SOFTWARE UPGRADE REPLACE CONTACT RING REINSTALLED SOFTWARE PROBABLE ROOT CAUSE: LIGHT ENGINE MALFUNCTION MAIN BOARD, RECEPTACLE BOARD, OR FRONT BOARD MALFUNCTION DAMAGED OR MISSING ESST SPRING INCORRECT/NO COMMUNICATION WITH 1688 OVERHEATING POWER SUPPLY MALFUNCTION SOFTWARE MALFUNCTION HF/RF INTERFERENCE CYBERSECURITY ATTACK THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
IT WAS REPORTED THAT LIGHT STARTS TO FLICKER AND TURNS OFF. THEREFORE, THERE WAS LOSS OF LIGHT. THE LIGHT CABLE WAS NOT THE ISSUE. THE LIGHT BOX HAD TO BE SWITCHED DURING THE CASE.
IT WAS REPORTED THAT LIGHT STARTS TO FLICKER AND TURNS OFF. THEREFORE, THERE WAS LOSS OF LIGHT. THE LIGHT CABLE WAS NOT THE ISSUE. THE LIGHT BOX HAD TO BE SWITCHED DURING THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1071175 | PKG L11 LED LIGHT SOURCE WITH AIM | CONFOCAL OPTICAL IMAGING | OWN | STRYKER ENDOSCOPY-SAN JOSE | 07613327455915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |