MAUDE Adverse Event Report: D.O.R.C INTERNATIONAL SHIELDED TOTALVIEW ENDOILLUMINATION PROBE INCLUDING ILLUMINATED SCLERAL DEPRESSO FIBER OPTIC ENDOILLUMINATION PROBE

Catalog Number 3269.SBS06

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2016

Event Type  malfunction  

Manufacturer Narrative

Device history lot review: unable to perform since the lot number is unknown. Sample analysis: it was determined on 13jun2017 that an examination of the returned light fiber revealed that the coating was melted as a result of direct contact with a hot object. The damaged coating causes the fiber not to function in a proper manner. Additionally, it was identified that the damage most likely originated from the outside rather than from within the fiber itself and strengthens our observation that an external heat source was the cause. The location of the damage was found to be located somewhere halfway between the connector and the hand piece and not anywhere near the patients eye. Conclusion: the complaint has not been found acknowledged. It is unknown when this incident occurred. We are not aware of any injury that occurred. Should any further information be obtained a supplemental report will be filed.

Event Description

An initial report has been received reporting "upon arriving the office manager at the center handed me a stack of bad product. " no further information was reported. The sample for this complaint has been returned and evaluated.

• Brand Name: SHIELDED TOTALVIEW ENDOILLUMINATION PROBE INCLUDING ILLUMINATED SCLERAL DEPRESSO
• Type of Device: FIBER OPTIC ENDOILLUMINATION PROBE
• Manufacturer (Section D): D.O.R.C INTERNATIONAL; kerkweg 47e; zuidland, netherlands 3214 VC; NL 3214 VC
• Manufacturer (Section G): DUTCH OPHTHALMIC USA; 10 continental dr; exeter NH 03833
• Manufacturer Contact: laura smith ; 10 continental dr; exeter, NH 03833 ; 6037786929
• MDR Report Key: 6703233
• MDR Text Key: 79911880
• Report Number: 1222074-2017-00005
• 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: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/13/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 3269.SBS06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial