PKG 1688 AIM 4K CAMERA HEAD C-MOUNT
Report
- Report Number
- 0002936485-2025-00165
- Event Type
- Malfunction
- Date Received
- March 5, 2025
- Date of Event
- February 19, 2025
- Report Date
- May 29, 2025
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- GCJ
- UDI-DI
- 07613327418989
- PMA / PMN Number
- K182160
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UPDATING REPORTABILITY AWARENESS DATE BASED ON FDA ACKNOWLEDGEMENT OF STRYKER ENDOSCOPY'S DECISION TO CEASE REPORTING FOR BLURRY IMAGES ON ENDOSCOPIC CAMERA SYSTEMS AND DEVICES.
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
PLEASE NOTE WE ARE DISCONTINUING THE CURRENT PRACTICE OF FILING MALFUNCTION MEDICAL DEVICE REPORTS (MDRS) FOR REPORTED COMPLAINTS RELATED TO BLURRY IMAGES ON STRYKER ENDOSCOPY'S ENDOSCOPIC CAMERA SYSTEMS AND DEVICES. THE CAMERA SYSTEMS ARE AN ENDOSCOPIC CAMERA SYSTEM THAT IS USED TO PRODUCE LIVE VIDEO IN THE SURGICAL FIELD DURING ENDOSCOPIC SURGICAL PROCEDURES. THE SYSTEM IS SENSITIVE IN THE VISIBLE AND INFRARED SPECTRUM. THE OPTICAL IMAGE IS TRANSFERRED FROM THE SURGICAL SITE TO THE CAMERA HEAD BY A VARIETY OF RIGID AND FLEXIBLE SCOPES, WHICH ARE ATTACHED TO THE CAMERA HEAD. THE SYSTEM CONSISTS OF A CAMERA CONSOLE AND A CAMERA HEAD WITH AN INTEGRAL CABLE THAT CONNECTS TO THE CONSOLE. A COUPLER IS ALSO AVAILABLE FOR ATTACHING A SCOPE TO THE CAMERA HEAD. THIS MALFUNCTION HAS NOT CAUSED OR CONTRIBUTED TO ANY DEATHS OR SERIOUS INJURIES IN THE LAST TWO YEARS. BASED ON THE INFORMATION PROVIDED, IT HAS BEEN DETERMINED THAT THIS MALFUNCTION IS UNLIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY SHOULD THE MALFUNCTION RECUR. THEREFORE, WE INTEND TO DISCONTINUE FILING MDRS FOR BLURRY IMAGES ON STRYKER ENDOSCOPY'S ENDOSCOPIC CAMERA SYSTEMS AND DEVICES.
ALLEGED FAILURE: BLURRY IMAGE CONFIRMED FAILURE: LEAK DUE TO CUT ON CABLE LENGTH REPLACE CABLE DEFORMED ENCLOSURE FRONT REPLACE FRONT ENCLOSURE DEFORMED REAR ENCLOSURE REPLACE REAR ENCLOSURE PROBABLE ROOT CAUSE: ¿ CABLES ¿ HDMI CABLES ¿ CONNECTORS ¿ DIGITAL BOARD ¿ POWER SUPPLY ¿ FILTER / FUSE ¿ AC INLET BOARD ¿ MAIN BOARD ¿ TRANSITION BOARD ¿ INTERMITTENCE BETWEEN TRANSITION BOARD AND CH CONNECTOR ¿ SOFTWARE ¿ CAMERA HEAD (SENSOR, SENSOR CABLE) ¿ COUPLER (DUST ON OPTICS, SCRATCHED OPTICS, BROKEN / SHIFTED LENSES, FOCUSING MECHANISM, ENDOCLAMP, ZOOM RING) ¿ PROBLEM TOGGLING LIGHT SOURCE ¿ CONNECTED MONITORS ¿ LEAKING ¿ POOR GROUNDING (E.G CAMERA HEAD CONNECTION FROM CABLE TO TRANSITION BOARD.) ¿ NO/INCORRECT COMMUNICATION WITH LIGHT SOURCE ¿ SOAKING CAP DISCONNECTION DURING STERILIZATION ¿ ELECTROMAGNETIC INTERFERENCE (EMI) FROM RF COMMUNICATION, HF SURGICAL INSTRUMENTS, ESD, OR POWER SURGE ¿ CYBERSECURITY ATTACK ¿ PENDULUM CH INERTIAL MEASUREMENT UNIT (IMU) ¿INCIDENT LIGHT FROM SURGICAL SCENE IS REFLECTED BY COUPLER/CH WINDOW ¿ USE ERROR THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2314484 | PKG 1688 AIM 4K CAMERA HEAD C-MOUNT | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | STRYKER ENDOSCOPY-SAN JOSE | 07613327418989 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |