MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIGATURE WITH PDS II; LAPROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number EZ10G

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Type  Injury  

Event Description

It was reported that the patient experienced preterm delivery on (b)(6) 2015 at the (b)(6) of gestation.After delivery, suture was found in the placenta and chorioamnionitis.The doctor opined that there was a possibility that inflammation reaction for suture caused the rupture of the membrane.The baby is in the nicu and is reported to be stable.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.Additional information: 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.

Manufacturer Narrative

It was reported that the suture did expel during the placental delivery and the baby received undefined medical treatment.No additional information was provided.(b)(4).

• Brand Name: ENDOLOOP LIGATURE WITH PDS II
• Type of Device: LAPROSCOPE, 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: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4769866
• MDR Text Key: 5779523
• Report Number: 2210968-2015-05653
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• 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 Received: 05/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EZ10G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention