MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1688 CAMERA CONTROL UNIT (CCU); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 1688010000

Device Problems Poor Quality Image (1408); Loss of Power (1475)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

Event Type  malfunction  

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.

Event Description

It was reported that there was loss of image.

Manufacturer Narrative

Alleged failure: ccu loses signal with monitor and turns off.Sending in camera as well, since they don't know which one is causing issue.Root cause: probable root cause could be attributed to a loose connection or a faulty power cable.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 there was loss of image.

• Brand Name: PKG, 1688 CAMERA CONTROL UNIT (CCU)
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11381864
• MDR Text Key: 234998422
• Report Number: 0002936485-2021-00112
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07613327420081
• UDI-Public: 07613327420081
• Combination Product (y/n): N
• PMA/PMN Number: K182160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1688010000
• Device Catalogue Number: 1688010000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 85