MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE BATTERY POWERED LIGHT SOURCE KIT; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 0503888028

Device Problems Fire (1245); Device Displays Incorrect Message (2591)

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

Event Date 02/14/2014

Event Type  malfunction  

Event Description

It was reported that the unit had caught fire and triggered a smoke alarm.This occured as the battery was charging in an office and not during a procedure.

Event Description

It was reported that the unit had caught fire and triggered a smoke alarm.This occured as the battery was charging in an office and not during a procedure.

Manufacturer Narrative

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

Manufacturer Narrative

Product was received for investigation.Assessment was conducted to determine the location of the product shipped for evaluation and the product could not be located.Therefore, the reported failure mode cannot be confirmed.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is found, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results.Root causes: blown capacitor.In sum, the product was received, but the failure mode cannot be confirmed.

• Brand Name: BATTERY POWERED LIGHT SOURCE KIT
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• 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: 3680549
• MDR Text Key: 4258833
• Report Number: 0002936485-2014-00113
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2014

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: 0503888028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2014
• Initial Date FDA Received: 03/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: No
• 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