MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SPY ELITE WITH SPY-Q; ANGIOGRAPHIC X-RAY SYSTEM

Catalog Number LC3000

Device Problem Smoking (1585)

Patient Problem No Information (3190)

Event Date 04/03/2018

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.(b)(4).

Event Description

It was reported that the device was emitting smoke.

Manufacturer Narrative

The product component was returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future re-occurrence.Alleged failure: unit (touchscreen) emitting smoke.Probable root cause: based on feedback communicated by rep, it is possible that the initial fluid ingress into the front of the panel caused a short which drastically increased current, resulting in damage to the traces and eventual failure.However, as no evidence of fluid ingress residue was observed following complete destructive disassembly of all components, this cannot be confirmed.It's also possible that given the service period of the touchscreen (originally released on 2011-09-29 as part of spy elite s/n: (b)(4), unit has surpassed the 50,000hr mtbf specified by the manufacturer and one or more power regulating smd components on the controller pcb failed.As touchscreen is an off-the-shelf component not manufactured or directly supported by novadaq/stryker, no further investigation is possible.As a precaution, emdr was submitted to fda regarding this incident on 2018-05-02 (pr# (b)(4).Touchscreen was replaced as part of scheduled field service.The device manufacturer date is not known.

Event Description

It was reported that the device was emitting smoke.

• Brand Name: SPY ELITE WITH SPY-Q
• Type of Device: ANGIOGRAPHIC X-RAY SYSTEM
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; burnaby; san jose CA 95138
• MDR Report Key: 7480382
• MDR Text Key: 107336199
• Report Number: 3012345110-2018-00001
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K100371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

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
• Device Operator: Other
• Device Catalogue Number: LC3000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 04/03/2018
• Supplement Dates FDA Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1