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

Model Number	1488010000
Medical Device Problem Code	Electrostatic Discharge (2149)
Health Effect - Clinical Codes	Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
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 there was electric shock to the user.
Additional Manufacturer Narrative
Alleged failure: unit shocked the nurse, this is the second incident.Update - shocked when unplugging the camera head from ccu after the case.No medical attention was needed.The shock was a strong shock that was stronger than a typical static shock from walking on carpet.The device will be returned once the loaner has been delivered.Complaint was submitted for the 1st incident (b)(6) 2021.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Root cause: it is difficult to determine the root cause of the issue observed at the account since we are unable to replicate the problem in-house.Possible root causes could be an electrosurgical generator or cautery pencil near the ccu.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that there was electric shock to the user.

• Brand Name: PKG, 1488 HD 3 CHIP CAMERA CONTROL UNIT (CCU)
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 14434482
• Report Number: 0002936485-2022-00254
• Device Sequence Number: 14763783
• Product Code: GCJ
• UDI-Device Identifier: 07613327061024
• UDI-Public: 07613327061024
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/03/2022

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: 1488010000
• Device Catalogue Number: 1488010000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 07/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown