FDA Adverse Event
Malfunction
Summary report: N
PKG, 1588 AIM CAMERA CONTROL UNIT (CCU)
MDR report key: 19293330
·
Received May 10, 2024
Report
- Report Number
- 0002936485-2024-00377
- Event Type
- Malfunction
- Date Received
- May 10, 2024
- Date of Event
- April 15, 2024
- Report Date
- July 9, 2024
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- OWN
- UDI-DI
- 07613327174328
- PMA / PMN Number
- K142310
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
ALLEGED FAILURE: EIB ALEXA, ONSITE. DURING ENT SINUS CASES SOMETIMES THE PICTURE HAS BEEN GETTING REALLY DARK. THE FAILURE ALLEGED IN THE COMPLAINT RECORD WAS NOT CONFIRMED/DUPLICATED DURING THE PRODUCT INVESTIGATION. PROBABLE ROOT CAUSES ARE: BAD DIGITAL BOARD. ADVISE TO REPLACE THE DIGITAL BOARD. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS DARK OF IMAGE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS DARK OF IMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2519471 | PKG, 1588 AIM CAMERA CONTROL UNIT (CCU) | CONFOCAL OPTICAL IMAGING | OWN | STRYKER ENDOSCOPY-SAN JOSE | 07613327174328 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |