MAUDE Adverse Event Report: FCI OPHTHALMICS INC RITLENG HOOK; HOOK, OPHTHALMIC

Catalog Number S1-1480U

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 08/31/2015

Event Type  malfunction  

Event Description

The ritleng hook was used during a procedure to pull a stent through nares.When the hook was removed it was noted that the tip of the hook was missing.An x-ray was obtained and a small object was noted in the image.The missing tip was found and removed.

• Brand Name: RITLENG HOOK
• Type of Device: HOOK, OPHTHALMIC
• Manufacturer (Section D): FCI OPHTHALMICS INC; 20 winter st; east pembroke MA 02359
• MDR Report Key: 5100054
• MDR Text Key: 26651408
• Report Number: 5100054
• Device Sequence Number: 1
• Product Code: HNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: S1-1480U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2015
• Device Age: 4 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 09/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 YR