MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 1688610122

Device Problems No Display/Image (1183); Loss of Power (1475)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2021

Event Type  malfunction  

Event Description

It was reported that there was loss of image.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: stopped working.Confirmed failure: deformed rear enclosure mechanical failure-endoclamp too tight-bent or broken reduced picture quality - lens spots.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.Coupler.Problem toggling light source.Connected monitors.Leaking.Poor grounding.No/incorrect communication with light source soaking cap disconnection during sterilization electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge pendulum ch inertial measurement unit (imu) use error manufacture date is not known.

Event Description

It was reported that there was loss of image.

• Brand Name: PKG, 1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: hannah stalnaker ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 12921049
• MDR Text Key: 283087635
• Report Number: 0002936485-2021-00687
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07613327418996
• UDI-Public: 07613327418996
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1688610122
• Device Catalogue Number: 1688610122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1