MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*MCA; CLIP, IMPLANTABLE

Catalog Number MCXXX

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Failure to Anastomose (1028); Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446)

Event Date 07/02/2002

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Accepted date for publication was july 2, 2002.This report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.

Event Description

It was reported that upon review of journal article, title: efficacy of absorbable clips compared with metal clips for cystic duct ligation in laparoscopic cholecystectomy.Authors: hiroshi yano, kazuyuki okada, masakatsu kinuta, yoshiaki nakano, takeshi tono, shigeo matsui, takashi iwazawa, toshiyuki kanoh, and takushi monden, citation: surg today.2003;33(1):18-23.Doi: 10.1007/s005950300003.The aim of this study was to determine whether lc using absorbable clips is safer and less invasive than lc using metal clips.Between september 1997 and december 2001, lc using absorbable clips (lc-ac) was performed in 328 patients with cholelithiasis, gallbladder polyps, adenomyomatosis, or cholecystitis at the department of surgery, ntt west osaka hospital.Another 444 patients who underwent the lc using metal clips (lc-mc) at our department between january 1992 and september 1997 were also evaluated as a control group.This study was carried out retrospectively, and we compared two populations operated on during different time periods.The ligaclip (ethicon, somerville, nj, usa), which is manufactured from titanium, was used in this study.After isolating the cystic duct in lc, the cystic duct was clipped with two metal clips on the patient¿s side and one clip on the gallbladder side.The cystic artery was also clipped with two metal clips on the patient¿s side and one clip on the gallbladder side during the same procedure.Reported complications included postoperative bleeding (n=11) in which 3 of the patients required laparatomy, wound infection(n=6), ileus (n=1), minor bile leak (n=2).In conclusion the results of this study suggest that absorbable.Clips are as safe and effective as standard metal.Clips for vessel and duct ligation in lc.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo ; *
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 12669316
• MDR Text Key: 278370786
• Report Number: 3005075853-2021-06312
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MCXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention