MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 4X30IN 5 S/A V-37; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	MB66G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Prolapse (2475)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Title: clinical efficacy of modified sacral fixation under leonardo da vinci robot laparoscopy for pelvic organ prolapse.The aim of this study was to analyze the clinical efficacy of modified sacral fixation under leonardo da vinci robot laparoscopy for pelvic organ prolapse (pop).Between (b)(6)2020 and (b)(6) 2021, a total of (b)(4) patients with pelvic organ prolapse (pop) were included in the study.These patients were divided into group a (laparoscopic y-mesh, (b)(4)), group b (laparoscopic sacrovaginal fixation, (b)(4)), and group c (da vinci robotic sacral fixation, (b)(4)).The subjects of the three groups were women.The average age, average prolapse time, and average deliveries were (63.16 ± 11.85) years old, (4.56 ± 1.28) years, and (2.56 ± 1.85) times in group a, respectively, (62.89 ± 10.74) years old, (4.39 ± 1.18) years and (2.46 ± 1.74) times in group b, and (62.78 ± 12.06) years old, (4.45 ± 1.12) years, (2.39 ± 1.12) times in group c.T patients in group a were treated with laparoscopic y-shaped mesh (brand: johnson & johnson, purchased in (b)(6) medical equipment sales co., ltd., (b)(6), china); both sides were interrupted sutured on the main sacral ligament complex, and the other end of the mesh was interrupted suture fixed to the anterior sacral longitudinal ligament in front of the s1 vertebral body by using the non-absorbable suture of aixibang mb66 (mb66g, johnson & johnson, (b)(6) medical equipment co., ltd.,(b)(6), china).The patients in group b were treated with modified mesh sacral fixation using two boot-shaped mesh (johnson & johnson, purchased in (b)(6) medical equipment sales co., ltd., (b)(6), china).Reported complications in group a include hemorrhagic (n=3), infection (n=2), mesh exposure (n=3), and recurrence (n=2).In group b include hemorrhagic (n=1) and mesh exposure (n=1).In conclusion, the efficacy of modified sacral fixation under leonardo da vinci robot laparoscopy for pop was comparable to that of laparoscopic y-mesh treatment and laparoscopic sacral vaginal fixation.However, da vinci¿s robotic sacral fixation had the advantages of less intraoperative bleeding and faster postoperative recovery, which helped patients recover quickly and improved their quality of life.
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.An attempt has been 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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.H6 component code: g07002 ¿ device not returned.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: european review for medical and pharmacological sciences 2023; 27: 6215-6222.

• Brand Name: EB EXC GRN 4X30IN 5 S/A V-37
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20335633
• Report Number: 2210968-2024-10404
• Device Sequence Number: 9592294
• Product Code: GAT
• UDI-Device Identifier: 10705031046290
• UDI-Public: 10705031046290
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Catalogue Number: MB66G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female