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Catalog Number W1770
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Foreign Body In Patient (2687)
Event Type  Malfunction  
Manufacturer Narrative

Product complaint # (b)(4). The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. Additional information was requested and the following was provided: can you please confirm whether or not the surgeon has been able to determine if the foreign object from the suture has been left implanted in the patient¿s eye? the surgeon alleged that foreign matter might be left on the patient eye considering that he felt something different while using the suture and identified potential foreign matter in the patient eye with his loupe. Please confirm if any medical or surgical intervention has been required? not yet required. But the surgeon want to know whether it's okay if the material is left in the eye. Photos of the eye, alleged foreign matter, or reported product issue would also be appreciated. No photo available. The surgeon said it can be only identified with his loupe, so photo cannot show the material. Are the quantities listed above the number of devices being returned (total 39)? yes. 39 ea of 4 different lots were returned. As the surgeon cannot confirm which lot number has the problem, he returned all open boxes of product in his facility. Did the surgeon use 1 suture of product w1770 during the procedure that felt something between needled and suture during penetrating cornea? he felt something between needle and suture with 4 or 5 sutures. Were 4 sutures of w1770 used on the one patient with issue between suture and needle? unknown. They might be used with multiple patients but the surgeon found a potential foreign matter in the eye of one patient. What were the ¿multiple¿ issues noted with the sutures being returned from 4 lots? see above. The surgeon experienced similar issue (felt something during penetrating cornea) with 4 or 5 sutures. Can you confirm ¿one of them he thought something is on cornea of patient¿ means 1 suture? while he felt something between need and suture but he found the potential foreign matter in one patient. 2nd additional information obtained: where is the foreign body located in the patient eye? the surgeon explained it is on the cornea. Does the foreign body affect the patient¿s vision in some way? the patient can not see the foreign body. How is the foreign body affecting the patients post operative care? the patient comes to hospital regularly, and surgeon exam that time. What is the opinion of the surgeon as to the identification of the foreign body? the foreign body from needle or suture. (clear color) 3rd additional information obtained: have you been able to confirm whether or not the alleged foreign matter was left in the patient¿s eye? yes, it is left in patient¿s eye. Has there been any medical or surgical intervention at this time in attempt to identify or retrieve the alleged foreign matter? no. Not yet. The surgeon strongly alleged the foreign material would be glue (in this case, epoxy). That¿s why the surgeon wants to know whether it¿s okay if the potential material stays left in the eye for long time. An opened folder with a parked needle-suture piece and a needle-suture combination inside an opened folder of product were returned for analysis. The product code is double armed. During the visual inspection of needle-suture piece, the swage and attachment area of needle were as expected, but, excess of epoxy was noted between the end barrel needle and the suture. The suture was examined along of strand and the end was cut appears to be by use of surgical instrument. In the visual inspection of the needle-suture, combination the swage and attachment area of needles were as expected, but, excess of epoxy was noted between the end barrel needle and the suture. The suture was examined along of strand and no defects were noted. Additionally, no marks on the needles were observed. The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch. Per the condition of the samples, the assignable cause of performance surface related defect ¿ needle, are excessive epoxy and stringy epoxy.

Event Description

It was reported a patient underwent an unknown eye surgery on an unknown date and suture was used. The surgeon had felt something between needle and suture during penetrating the cornea. So he alerted the nurse. He thought something was on cornea of patient. So he tried to remove it but unable to.

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Manufacturer (Section D)
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
MDR Report Key8175423
MDR Text Key130901234
Report Number2210968-2018-77847
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberK946173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 11/25/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/18/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Catalogue NumberW1770
Device LOT NumberUNK, MCQ928
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/07/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/28/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial