MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1488 HD 3 CHIP CAMERA CONTROL UNIT (CCU) WITH DVI FIBER OUTPUT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 1488010001

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Electro-Static Discharge (2149)

Patient Problems Shock from Patient Lead(s) (3162); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2020

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 the user was shocked.

Manufacturer Narrative

Alleged failure: nurse was shocked when unplugging camera from ccu.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Root cause: camera head conforms to specifications.The most provable root cause could be damaged power cord or electrical static discharge when connecting the unit.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the user was shocked.

• Brand Name: PKG, 1488 HD 3 CHIP CAMERA CONTROL UNIT (CCU) WITH DVI FIBER OUTPUT
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11211349
• MDR Text Key: 229092525
• Report Number: 0002936485-2021-00046
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07613327061017
• UDI-Public: 07613327061017
• Combination Product (y/n): N
• PMA/PMN Number: K132785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1488010001
• Device Catalogue Number: 1488010001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1