MAUDE Adverse Event Report: WECK / TELEFLEX MEDICAL INC. WECK OPHTHALMIC MUSCLE HOOK; HOOK, OPTHALMIC

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/10/2019

Event Type  malfunction  

Event Description

During procedure ophthalmic muscle hook snapped and broke in pt's left eye.X-ray performed in operating room suite and showed a metallic foreign body in the orbit.Oculoplastic surgeon/orbital specialist consulted.Since foreign body was surgical stainless steel it was inert in the orbit.Further exploration at this time not recommended.F/u appts with surgeon and specialist scheduled.Fda safety report id# (b)(4).

• Brand Name: WECK OPHTHALMIC MUSCLE HOOK
• Type of Device: HOOK, OPTHALMIC
• Manufacturer (Section D): WECK / TELEFLEX MEDICAL INC.
• MDR Report Key: 8624815
• MDR Text Key: 145754918
• Report Number: MW5086768
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR