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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL JAMESON MUSCLE HOOK; HOOK, OPHTHALMIC
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TELEFLEX MEDICAL JAMESON MUSCLE HOOK; HOOK, OPHTHALMIC Back to Search Results
Catalog Number 421200
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/10/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
Medwatch #mw5086768.The complaint states that during the procedure the ophthalmic muscle hook snapped and broke it the patient's left eye.An x-ray was performed in the operating room suite and it showed a metallic foreign body in the orbit.An oculoplastic surgeon/orbital specialist was consulted.Since the foreign body was surgical stainless steel it was inert in the orbit.Further exploration at this time not recommended.Follow-up appointments were scheduled with the surgeon and specialist.
 
Manufacturer Narrative
Qn#(b)(4).Additional information indicates that the patient had surgical removal of the metallic foreign body in the orbit.
 
Event Description
Medwatch #mw5086768.The complaint states that during the procedure the ophthalmic muscle hook snapped and broke it the patient's left eye.An x-ray was performed in the operating room suite and it showed a metallic foreign body in the orbit.An oculoplastic surgeon/orbital specialist was consulted.Since the foreign body was surgical stainless steel it was inert in the orbit.Further exploration at this time not recommended.Follow-up appointments were scheduled with the surgeon and specialist.
 
Manufacturer Narrative
Qn#(b)(4).Device history record (dhr) was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 421200.A visual inspection of the product involved in the complaint could not be conducted since the product was not returned.The customer's photos illustrate a hook with a broken tip , but the etching is not legible to determine device or lot#.No confirmed complaints were received in this range with the same issue.Device history record (dhr) was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 421200.A sample is needed for a proper root cause identification.
 
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Brand Name
JAMESON MUSCLE HOOK
Type of Device
HOOK, OPHTHALMIC
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8749141
MDR Text Key149766855
Report Number3011137372-2019-00224
Device Sequence Number1
Product Code HNQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number421200
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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