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

Catalog Number PC9001

Device Problems Device Emits Odor (1425); Smoking (1585); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

Mfg date: 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.Gtin will be provided in future reports.

Event Description

It was reported that smoke and a burning smell came out of the rear panel of the vpi.The device did not function after.

Manufacturer Narrative

The failure identified in the investigation is consistent with the complaint record.Reportability decision was checked for consistency.The reported failure mode will be monitored for future reoccurrence.Alleged failure: "lymphatic vessel was imaged by using vpi and spyphi.Vpi was used for about 40 min.When the spyphi was handed at the end of the procedure, a noise arose and the monitor black out.A smoke came our from the duct of the vpi rear panel and smelled of burn.The device could not be booted up anymore." probable root cause: reported failure to power up was caused by a faulty vpi power supply.Power supply failures were investigated under p283dn208 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 device manufacturer date is not known.

Event Description

It was reported that smoke and a burning smell came out of the rear panel of the vpi.The device did not function after.

• 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
• MDR Report Key: 7638931
• MDR Text Key: 112474189
• Report Number: 3012345110-2018-00002
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K150956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PC9001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Date Manufacturer Received: 05/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1