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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KIRWAN SURGICAL PRODUCTS LLC. BIPOLAR FORCEPS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

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KIRWAN SURGICAL PRODUCTS LLC. BIPOLAR FORCEPS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number 19-5046AUIR
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Other
Event or Problem Description
I have notified kirwan surgical products of packaging issues with some of their disposable bipolar forceps.One example is product # 19-5046auir.Back in april, one of my surgical techs noticed holes in the packaging of one of the forceps.After examining it, i decided to look at the rest of our supply since i figured if it could happen to one, the others might have the same issues.When i examined them, we had over 30 bipolar forceps that had some form of holes either in the paper part of the packaging or the clear section of the packaging.The holes appeared to be a pair of holes that all appeared at the end of the product where the disposable bipolar cord would plug into the 2 prongs on the bipolar forcep.It appears that they are hitting the packaging from the interior and either dimpling them bad enough to appear to look like holes or actual holes are present.I thought that it could be the way we were storing them, but i thought i would look at a brand new box to see if they were arriving damaged.When i unboxed it in front of my director, manager and materials person, we discovered that the undamaged box was well packaged with bubble wrap, but they actually had holes or dimpling in the packages already.I called the company and they initially gave me an rma for the bipolars and they were returned.I told them that they need to change their packaging and put a soft rubber or silicone cover over the 2 prongs.They actually have coverings over the tips of the bipolar, but not on the end where the cord is plugged into.We have since continued to have issues with finding more packages with holes.I finally reached back out to them recently and they said that they wanted pictures because they do not have any other complaints.I sent them the pictures from back in april (which i had sent before) and they sent a letter back saying that they think it is our handling and they have no other complaints.I told them that the reason that they are probably not getting any complaints is because the holes are very small and if people are not aware of the issues, they may not see it.I asked them if they should send out a notice to their users and warn them to inspect carefully and they have not responded other than to say that they do not seem to think it is an issue.I wanted to inform you that i think this company should redo their packaging for patient safety since there has been multiple issues of packaging with holes and enough that cannot be determined if there has been a breach in sterility and have therefore been disposed of.Please consider informing them that they must repackage and also notify their customers of this patient safety issue.Reference reports: mw5161856, mw5161857, mw5161858, mw5161859, mw5161860, mw5161861, mw5161862, mw5161863, mw5161864, mw5161865, mw5161866, mw5161867, mw5161868, mw5161870, mw5161871, mw5161872, mw5161873, mw5161874, mw5161875, mw5161876, mw5161877, mw5161878, mw5161879, mw5161880, mw5161881, mw5161882, mw5161883, mw5161884, mw5161885.
 
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Brand Name
BIPOLAR FORCEPS
Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
KIRWAN SURGICAL PRODUCTS LLC.
MDR Report Key20567386
Report NumberMW5161869
Device Sequence Number19251917
Product Code GEI
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 10/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model Number19-5046AUIR
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/29/2024
Patient Sequence Number1
Patient SexUnknown
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