Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AB MEDICA SAS AB MEDICA CURVED SCISSOR AND INSERT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AB MEDICA SAS AB MEDICA CURVED SCISSOR AND INSERT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number LIL-IP-2SC-20ST
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2022
Event Type  malfunction  
Event Description
The requalification of our thermosealing process showed a non conformity on our sealings.After further investigation, the tyvek batch used in theses sealings has been found non conformant because the seal width is smaller than expected.The evaluation of the non-conformity showed that this batch has been used in product packaging distributed in the us.This defect is not affecting the sterile state of the product since the integrity testing according to astm f 1929 has been found conform.For the first test, 9 products were found non conformant by the laboratory rescoll finding that the seal width was 3 to 5.5mm on those 9 products whereas it is required at least 6 mm.The second test realized in the same laboratory was conform on all 27 products tested demonstrating that the packaging remains sealed.Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AB MEDICA CURVED SCISSOR AND INSERT
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
AB MEDICA SAS
MDR Report Key14801183
MDR Text Key294939365
Report NumberMW5110491
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/21/2022
9 Devices were Involved in the Event: 1   2   3   4   5   6   7   8   9  
1 Patient was Involved in the Event
Date FDA Received06/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLIL-IP-2SC-20ST
Device Catalogue NumberLIL-IP-2SC-20ST
Device Lot NumberEK07210008
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-