MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE X8000 LIGHTSOURCE; LIGHT, SURGICAL, FLOOR STANDING

Catalog Number 0220200000

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2014

Event Type  malfunction  

Event Description

It was reported that there was an alleged current on the outer surface of the light source.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Manufacturer Narrative

The device(s) was not received for investigation at stryker endoscopy because it was repaired locally in (b)(4).Current is being sensed on outer surface of x8000 light source.The device was repaired and there is no longer any current being sensed on the surface.The reported event involving this failure and device could have been caused by: improper assembly; external fluids enter unit; defective connectors; improper grounding; use error.In sum, the reported failure was confirmed at (b)(6).The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.       .

Event Description

It was reported that there was an alleged current on the outer surface of the light source.

• Brand Name: X8000 LIGHTSOURCE
• Type of Device: LIGHT, SURGICAL, FLOOR STANDING
• 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: thomas shafer ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 4348611
• MDR Text Key: 5139597
• Report Number: 0002936485-2014-01030
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K961971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0220200000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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