MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1588 AIM CAMERA CONTROL UNIT (CCU); CONFOCAL OPTICAL IMAGING

Catalog Number 1588010000

Device Problems No Display/Image (1183); Loss of Power (1475); Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the ccu shut off completely.The cameras powered off when they switched from cysto to lap.When they tried to hit the power button, it did not come on.When they tried a third time, it came on but the screen was black.The ccu did not give a picture output.It powered off again without camera plugged in.After the ccu booted up, they plugged in the camera and got a picture.The image was lost for 1-2 minutes during a non-critical point of the surgery.Although there was patient involvement, there were no adverse consequences.

Manufacturer Narrative

Product was received in-house at stryker endoscopy; the failure mode could not be confirmed.Device inspection: console in excellent condition (serial: (b)(4)); no cosmetic issues, turns on and works.Probable root cause: could not replicate issue, thus could not determine probable root cause.The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the ccu shut off completely.The cameras powered off when they switched from cysto to lap.When they tried to hit the power button, it did not come on.When they tried a third time, it came on but the screen was black.The ccu did not give a picture output.It powered off again without camera plugged in.After the ccu booted up, they plugged in the camera and got a picture.The image was lost for 1-2 minutes during a non-critical point of the surgery.Although there was patient involvement, there were no adverse consequences.

• Brand Name: PKG, 1588 AIM CAMERA CONTROL UNIT (CCU)
• Type of Device: CONFOCAL OPTICAL IMAGING
• 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: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 5140683
• MDR Text Key: 28347752
• Report Number: 0002936485-2015-00898
• Device Sequence Number: 1
• Product Code: OWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1588010000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2015
• 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