FDA Adverse Event
Malfunction
Summary report: N
PKG, L11 LED LIGHT SOURCE WITH AIM
MDR report key: 19084516
·
Received April 10, 2024
Report
- Report Number
- 0002936485-2024-00313
- Event Type
- Malfunction
- Date Received
- April 10, 2024
- Date of Event
- April 3, 2024
- Report Date
- July 3, 2024
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- OWN
- UDI-DI
- 07613327455915
- PMA / PMN Number
- K182160
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 0
ALLEGED FAILURE: EIB, SIMMS, REP, THE LIGHT WAS TURNING ON AND OFF DURING THE CASE., (B)(4). *DELAY : 5 MINUTES. [UPDATE - LOSS OF LIGHT DURATION CANNOT BE CONFIRMED.] THE FAILURE ALLEGED IN THE COMPLAINT RECORD WAS NOT CONFIRMED/DUPLICATED DURING THE PRODUCT INVESTIGATION. THE PROBABLE ROOT CAUSE: ADVISE TO REPLACE FRONT PANEL AND JAW HANDLE. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1230972 | 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 |