MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIGATURE UNKNOWN PRODUCT; CANNULA, SURGICAL, GENERAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Citation: world j surg (2010) 34: 765¿767; doi 10.1007/s00268-009-0365-z.(b)(4).

Event Description

It was reported via journal article: title: "a time-saving technique for specimen extraction in sleeve gastrectomy." author(s): giovanni casella, emanuele soricelli, aldo fantini, nicola basso.Citation: world j surg (2010) 34: 765¿767; doi 10.1007/s00268-009-0365-z.This study aimed to describe the technique for specimen extraction used in more than 250 laparoscopic sleeve gastrectomy performed.Since oct2002, more than 250 obese patients underwent sleeve gastrectomy (sg).Sg was performed using either linear stapler endo-gia or echelon endopath with gold cartridges.In the first 90 lsg patients, specimen was extracted in a retrieval bag using an endoloop; in the following 160 cases, the grasped specimen was withdrawn through 15-mm trocar site without any additional device.Closure of trocar site was achieved with a vicryl 1-0 cross stitch, using a bercy needle.Overall, there were only two cases of wound infection using this technique.This complication did not occur in the subsequent 130 cases in which the trocar-access site was disinfected with povidone-iodine solution.The gastric emptying before the resection, the gentle traction of the specimen without rupture, and the thorough disinfection of the trocar-access site seem to be key to decreasing the incidence of wound infection.

• Brand Name: ENDOLOOP LIGATURE UNKNOWN PRODUCT
• Type of Device: CANNULA, SURGICAL, GENERAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8200459
• MDR Text Key: 131544878
• Report Number: 2210968-2018-78051
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention