MAUDE Adverse Event Report: DUTCH OPHTHALMIC SHEILDED TOTALVIEW ENDOILLUMINATION PROBE

Catalog Number 3269.SBS06

Device Problem Device Issue (2379)

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

Event Date 03/14/2017

Event Type  malfunction  

Manufacturer Narrative

The device underwent an investigation and is now complete on the light fiber product 3269.Sbs06, lot 1905129 reported and returned to us.The device history lot review: the lot meet the specification outlined for release.We have not received any similar complaints on this lot.We have not received any information of same or similar like events that pertain to this lot or on any other lot of this same or similar manufactured product.Sample analysis: it was detected that the outside of the fiber was melted.This fiber component was produced at a different manufacturer.It is unknown how this occurred.It is possible that the gladding of the fiber was damaged during production, therefore heat was able to build up.Conclusion: the lot reported meets the specification outlined for release and is considered an isolated incident.Please note that should any further information be received, we will submit a supplemental report.

Event Description

A report has been received reporting that the probe had started smoking.A call was placed to user facility for additional information.It was reported the incident occurred during surgery while idle but connected to the light source.No injury occurred.

• Brand Name: SHEILDED TOTALVIEW ENDOILLUMINATION PROBE
• Type of Device: ILLUMINATION PROBE
• Manufacturer (Section D): DUTCH OPHTHALMIC; 10 continental dr; exeter NH 03833
• Manufacturer (Section G): DUTCH OPHTHALMIC USA; 10 continental dr; exeter NH 03833
• Manufacturer Contact: laura smith ; 10 continental dr; exeter, NH 03853 ; 6037786929
• MDR Report Key: 6482040
• MDR Text Key: 72790027
• Report Number: 1222074-2017-00001
• Device Sequence Number: 1
• Product Code: FFS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/16/2017

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: Physician
• Device Expiration Date: 05/01/2021
• Device Catalogue Number: 3269.SBS06
• Device Lot Number: 1905129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1