MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE UNKNOWN_ENDOSCOPY_PRODUCT; LIGHT SOURCE, FIBEROPTIC, ROUTINE

Catalog Number UNK_END

Device Problems Thermal Decomposition of Device (1071); Failure to Shut Off (2939)

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

Event Date 09/25/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that light did not turn off.It was disconnected and burned the drape light source would not turn off when standby button was pushed.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.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 caused by: safelight design, boot material, light source.

Event Description

It was reported that light did not turn off.It was disconnected and burned the drape light source would not turn off when standby button was pushed.

• Brand Name: UNKNOWN_ENDOSCOPY_PRODUCT
• Type of Device: LIGHT SOURCE, FIBEROPTIC, ROUTINE
• 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: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 5164333
• MDR Text Key: 29220071
• Report Number: 0002936485-2015-00933
• Device Sequence Number: 1
• Product Code: FCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK 510(K)
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNK_END
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2015
• 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