PKG L10 LED LIGHT SOURCE WITH AIM
Report
- Report Number
- 0002936485-2025-00323
- Event Type
- Malfunction
- Date Received
- April 9, 2025
- Date of Event
- March 13, 2025
- Report Date
- June 26, 2025
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- OWN
- UDI-DI
- 07613327051377
- PMA / PMN Number
- K142310
- 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: DELAYED A COUPLE OF MINUTES CONFIRMED FAILURE: MISSING HANDLE REPLACED JAW HANDLE HARDWARE UPGRADE (NPF) REPLACE CONTACT ESST SPRING REPLACE CONTACT RING PROBABLE ROOT CAUSE: DAMAGED LIGHT CABLE DAMAGED SCOPE DAMAGED COUPLER DAMAGED LEDS MAIN BOARD MALFUNCTION LOOSE / MISALIGNED JAW ASSEMBLY LIGHT ENGINE/ LIGHT PIPE MALFUNCTION OR DAMAGED BENT ESST CONTACT INCONSISTENT ESST CONTACT CAMERA HEAD COMMUNICATION FRONT BOARD MALFUNCTION TOUCH PANEL MALFUNCTION POWER SUPPLY MALFUNCTION THERMAL SWITCH MALFUNCTION AC INLET BOARD MALFUNCTION INADEQUATE AIR FLOW SIDNE PORT MALFUNCTION POOR WORKMANSHIP INADEQUATE CALIBRATION USE ERRORS ELECTROMAGNETIC INTERFERENCE (EMI) FROM RF COMMUNICATION, HF SURGICAL INSTRUMENTS, ESD, OR POWER SURGE THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ADDED INITIAL REPORTER PHONE.
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1665437 | PKG L10 LED LIGHT SOURCE WITH AIM | CONFOCAL OPTICAL IMAGING | OWN | STRYKER ENDOSCOPY-SAN JOSE | 07613327051377 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |