MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1588 AIM CAMERA HEAD WITH INTEGRATED COUPLER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	1588610122
Medical Device Problem Code	Electrostatic Discharge (2149)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	03/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacture 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 a user was shocked.
Additional Manufacturer Narrative
Alleged failure: camera shocked the surgeon.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 duplicate the problem in-house.Possible root causes could be other equipment used along with the camera head when the issue occurred.The product was returned for investigation and the failure mode will be monitored for future re-occurrence.Manufacture date is not known.
Event or Problem Description
It was reported that a user was shocked.

• Brand Name: PKG, 1588 AIM CAMERA HEAD WITH INTEGRATED COUPLER
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9986821
• Report Number: 0002936485-2020-00174
• Device Sequence Number: 4442567
• Product Code: GCJ
• UDI-Device Identifier: 07613327174380
• UDI-Public: 07613327174380
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K132785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1588610122
• Device Catalogue Number: 1588610122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 06/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other