MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*MULTIFEED STAPLER; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number EMS

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Seroma (2069); Urinary Retention (2119); Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown.Batch # unknown.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported via journal article: title: "a novel technique for laparoscopic hernioplasty: experience with the laparoscopic application of the prolene hernia system (phs®)." authors: i.Mairshon-simion, k.Dayan, o.Landau, s.Keyzer, i.Charuzi, m.Muggia-sullarn.Citation: a novel technique for laparoscopic hernioplasty.435-438.Large inguinal defects pose a special problem with the laparoscopic repair of inguinal hernias (lrih).A novel technique has been developed applying the prolene hernia system (phs; ethicon) laparoscopically.The objectives of the study was to review the experience and results of consecutive lrih with application of the phs, and to compare them to standard techniques.A total of 979 patients underwent lrih (81% male patients; age range: 19 to 94 years old) and were included in the study.Of which, phs was applied in 183 patients.During the surgical procedure, 3 types of repairs were performed, type iii, phs with an overlying regular mesh.The intermediate or large phs was used.The phs mesh was fixated by 1 or 2 5-mm tackers and over the under-lay patch a second mesh (15 x 12 cm) was placed with a regular fixation.The peritoneum was closed, whenever opened, with endopath endoscopic multifeed stapler (ethicon).Reported complications included intra-abdominal hematoma (n-1) which was treated conservatively by blood transfusion, elevated temperature without obvious infection (n-15) which subsided without any further treatment, urinary retention (n-17) which was treated by insertion of an indwelling urinary catheter and 1 patient was treated on an out-patient basis, wound seroma (n-14) which was treated by needle aspiration, and recurrent hernia (n-1).The phs may be applied laparoscopically.It may lower the recurrence rate of inguinal defects without increasing complications and without major differences in operative time.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8455213
• MDR Text Key: 139970409
• Report Number: 3005075853-2019-17576
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K913469
• 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: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EMS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1