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
Medical Device Problem Code	Electrostatic Discharge (2149)
Health Effect - Clinical Codes	Shock from Patient Lead(s) (3162); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the user was shocked.
Additional 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 or Problem Description
It was reported that the user was shocked.

• Brand Name: PKG, 1488 HD 3 CHIP CAMERA CONTROL UNIT (CCU) WITH DVI FIBER OUTPUT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11211349
• Report Number: 0002936485-2021-00046
• Device Sequence Number: 3795206
• Product Code: GCJ
• UDI-Device Identifier: 07613327061017
• UDI-Public: 07613327061017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1