MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIGATURE UNKNOWN PRODUCT; LAPROSCOPE, GENERAL & PLASTIC SURGERY

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Seroma (2069); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that any deficiency of the ethicon product vicryl, silk or endoloop suture caused and/or contributed to the adverse events described in the article? citation: journal of laparoendoscopic & advanced surgical techniques volume 28, number 1, 2018 ª mary ann liebert, inc.; doi: 10.1089/lap.2017.0045 please see attached referenced article (b)(4).

Event Description

Title: the novel technique of transabdominal preperitoneal hernioplasty herniorrhaphy for direct inguinal hernia: suture repair of hernia defect wall it was reported in a journal article: the purpose of this study was to evaluate the efficacy of defect wall suture of laparoscopic herniorrhaphy for direct inguinal hernia patients (transabdominal preperitoneal hernioplasty (tapp) and totally extraperitoneal hernioplasty).Between september 2012 to december 2015, 210 (ctapp n=99(87 males, 12 females), rtapp n=111 (106 males, 5 females)) direct inguinal patients were evaluated to be included in this study.The patients were categorized into two groups according to tapp techniques; ctapp group had conventional tapp without defect wall suture, and rtapp group had defect wall suture tapp.There were 99 patients in a ctapp group and 111 patients in rtapp group.In ctapp, a wide peritoneal area, including indirect area, was dissected, and lax transversalis was ligated with an endoloop.Mesh was placed in the peritoneal space without suture fixation, and then the peritoneum was closed with a continuous absorbable suture (vicryl 3¿0).In rtapp, the direct hernia defect was closed using suture with a non-absorbable multifilament (silk 1¿0).Complications included seroma (n=3), chronic pain (n=1) in ctapp group and hematoma (n=1) in rtapp group.Bulging phenomenon (n=2) were also noted in ctapp group.After the syringe aspiration, all the seroma subsided.Bulging phenomenon (n=2) was only observed in ctapp group.In conclusion, in the laparoscopic direct inguinal hernia treatment, hernia defect wall closure technique with continuous running suture can reduce the dissection area and minimize the risk of injury of important organs in the indirect area.Additional information was requested.

• Brand Name: ENDOLOOP LIGATURE UNKNOWN PRODUCT
• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 7379436
• MDR Text Key: 103787105
• Report Number: 2210968-2018-71725
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2018
• 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