MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIGATURE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); No Code Available (3191)

Event Date 02/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that the patient underwent a laparoscopic appendectomy six years ago and suture was used.On (b)(6) 2016, the plastic sheath of the suture was removed.The patient experienced ongoing abdominal pain and x-rays with two ct scans were performed which yielded no obvious results due to the sheath not being radio opaque.It was also reported that the patient was exposed to significant doses of radiation and developed adhesions caused by the foreign body response and resulted in damaged right ovary and bowel adhesions.Then the surgeon opines that unusual adverse event is not a device failure, but a surgical error.Additional information was requested.

Manufacturer Narrative

It was reported that the suture sheath was removed on (b)(6) 2016 with minimal dissection from the omentum and mesocolon.

• Brand Name: ENDOLOOP LIGATURE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra, km 1; 54; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5470005
• MDR Text Key: 39337729
• Report Number: 2210968-2016-05535
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 21 YR