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 Problem Shock (2072)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that a user was shocked.

Manufacturer Narrative

Alleged failure: todd or shocked when plugged in.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.Manufacture date is not known.

Event Description

It was reported that a 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: 9750878
• MDR Text Key: 184259841
• Report Number: 0002936485-2020-00078
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/04/2020
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/25/2020
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1