• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIGATURE WITH PDS II LAPROSCOPE, 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
 

ETHICON INC. ENDOLOOP LIGATURE WITH PDS II LAPROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number EZ10G
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problems Fever (1858); Unspecified Infection (1930); Inflammation (1932); Other (for use when an appropriate patient code cannot be identified) (2200); Reaction (2414); Treatment with medication(s) (2571)
Event Type  Injury  
Manufacturer Narrative

It was reported that the decidual polyp was a cervical polyp. The suture did expel during the placental delivery. The surgeon opines that the early birth was due to the polypectomy at 11 weeks of gestation. No additional information was provided.

 
Event Description

It was reported that the patient underwent surgical procedure at (b)(6) week of gestation to remove a polyp on an unknown date and suture was used. At the (b)(6) week, the patient experienced preterm prom. The patient experienced a high fever on an unknown date. The patient was administered an antibiotic and steroid for fetal pulmonary maturation. The patient had an unavoidable delivery at the(b)(6) of gestation and successfully gave birth on (b)(6) 2015. After delivery, suture was found in the placenta and it was reported the patient experienced chorioamnionitis. The doctor opined that there was a possibility that inflammation reaction for suture caused the rupture of the membrane. The patient is in the hospital and is reported to be stable. Additional information has been requested.

 
Manufacturer Narrative

Date sent to the fda: 05/13/2015 conclusion: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. The actual device batch number associated with this event is not known. The international affiliate reports the following possible batch numbers: batch hdx180; mfg date: 05/2014; exp date: 01/2019. In addition, a review of the batch manufacturing records for the possible batch number was conducted and the batches met all finished goods release criteria.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENDOLOOP LIGATURE WITH PDS II
Type of DeviceLAPROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 015
Manufacturer (Section G)
ETHICON INC.-BRAZIL
rodovia presidente dutra, km 1
54
sao paolo 1224 0-90
BR 12240-908
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key4769818
MDR Text Key13458039
Report Number2210968-2015-05652
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK925914
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/15/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/30/2019
Device Catalogue NumberEZ10G
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/14/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/30/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/13/2015 Patient Sequence Number: 1
-
-