MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SAFELIGHT FIBER OPTIC CABLE CLEAR; LIGHT, SURGICAL, FLOOR STANDING

Catalog Number 0233050100

Device Problems Thermal Decomposition of Device (1071); Device Operates Differently Than Expected (2913)

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

Event Date 05/08/2014

Event Type  malfunction  

Event Description

It was reported that the light source did not go to stand by and burned the drape.The patient was not burned or harm.There was no delay.

Event Description

It was reported that the light source did not go to stand by and burned the drape.The patient was not burned or harm.There was no delay.

Manufacturer Narrative

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

Manufacturer Narrative

The reported device was not received for investigation; therefore, the reported failure 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 received, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been probably caused by: safelight design; boot material; light source.In sum, the reported failure could not be confirmed since the device was not received at stryker endoscopy for investigation.

• Brand Name: SAFELIGHT FIBER OPTIC CABLE CLEAR
• 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: 3842518
• MDR Text Key: 4614626
• Report Number: 0002936485-2014-00379
• Device Sequence Number: 0
• Product Code: FST
• Reporter Country Code: US
• PMA/PMN Number: K961971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0233050100
• Device Lot Number: UKN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2014
• Initial Date FDA Received: 06/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/17/2014
• 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