MAUDE Adverse Event Report: ETHICON INC. 0 ENDOLOOP LIG W/PDS II; LAPROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number EZ10G

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Vomiting (2144); Not Applicable (3189); No Code Available (3191)

Event Date 02/01/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: date of the initial surgical procedure? (b)(6) 2013.Were any concomitant procedures performed? only appendectomy.Were there any other complications during the procedure? no.What were current symptoms following the index surgical procedure? the patient came to the hospital because of stomach ache and emesis.Ct scan was performed and the conservative treatment was performed.Onset date? (b)(6) 2014.What is meant by ¿funicular substance¿? it was reported as ""a transparent suture, which seemed to be the suture of the ez10g which was used to ligate the proximal end of appendix at the primary surgery.During reoperation were there any adhesion noted? no.Only ileum.What is physician¿s opinion as to the etiology of or contributing factors to this event? dr.Commented that the remained suture of ez10g after ligation was long and the adhesion occurred because of this suture on mesentery of the ileum.And the ileum was wringed the space of this adhesion and the strangulated ileus occurred.The remained suture was cut and the strangulated point was opened.Because there was no necrosis site of ileum, the ileum was not cut.The remained suture of ez10g should be cut in short.

Event Description

It was reported that the patient underwent laparoscopic appendectomy in (b)(6) 2013 and suture was used.In (b)(6) 2014, the patient returned to the hospital with stomach ache and emesis.Ct scan was performed.The patient was diagnosed with a strangulated ileus and underwent emergency re-operation.The ileum was compressed by a funicular substance and in the core was a transparent suture which seemed to be the suture that was used to ligate the proximal end of appendix during the initial procedure.The funicular substance was removed.The physician opined that the remained suture after ligation was long and the adhesion occurred because of this suture on mesentery of the ileum; the ileum wringed the space of this adhesion and the strangulated ileus occurred.It was reported that the remained suture was cut and the strangulated point was opened.Because there was no necrosis site of ileum, the ileum was not cut.The patient fully recovered and left the hospital.No additional information was provided.

• Brand Name: 0 ENDOLOOP LIG W/PDS II
• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 15; sao paolo ; BR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7060160
• MDR Text Key: 92963438
• Report Number: 2210968-2017-71430
• Device Sequence Number: 1
• Product Code: GEA
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• 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?: No
• Date Manufacturer Received: 10/30/2017
• 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: 26 YR