MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE VIDEO PROCESSOR/ILLUMINATOR (VPI); ENDOSCOPE VIDEO IMAGING SYSTEM

Catalog Number PC9001

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the user received an electric shock from the device.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: as reported by stryker representative "i was electrical shocked up into my arm when pressing the power button on a vpi console.This was followed by crackling and smoking".Probable root cause: the loss of power on the vpi was caused by a power supply failure.Power supply failures were investigated under (b)(4) concluding that the manufacturer is aware of the failure mode and have been constantly implementing corrective actions to reduce the failure rate.As a precaution, the engineering team is currently further assessing the need for a supplier change and/or redesign on the current vpi power supplies.The tests conducted show that the device is properly grounded and could not cause an electrical shock to the user under normal conditions.It has been noted that during power supply failure a slight and brief current surge is emitted through the system.Based on these facts, it is believed that the external grounding connected to the vpi was faulty thus providing improper grounding to the device.The operator would have had to be touching an exposed conductive surface at the exact time of the power supply failure in conjunction with the faulty external grounding in order to experience a shock from the discharge.Reportability reviewed for consistency and confirmed.Manufacture date is not known.

Event Description

It was reported that the user received an electric shock from the device.

• Brand Name: VIDEO PROCESSOR/ILLUMINATOR (VPI)
• Type of Device: ENDOSCOPE VIDEO IMAGING SYSTEM
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; burnaby; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; burnaby; san jose CA 95138
• Manufacturer Contact: victoria milich ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7864391
• MDR Text Key: 120280745
• Report Number: 3012345110-2018-00008
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 85870100604
• UDI-Public: 85870100604
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: PC9001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1