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

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

Patient Problems Failure to Anastomose (1028); Not Applicable (3189)

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 manufacturing record evaluation cannot be reviewed as the lot number has not been provided.Citation: it was reported via journal article: title: bile leakage following laparoscopic cholecystectomy.Authors: j.L.A.Albasini, v.S.Aledo, s.P.L.Dexter, j.Marton, i.G.Martin, m.J.Mcmahon citation: surg endosc (1995); 9:1274-1278.[(b)(4)].

Event Description

It was reported via journal article: it was reported via journal article: title: bile leakage following laparoscopic cholecystectomy authors: j.L.A.Albasini, v.S.Aledo, s.P.L.Dexter, j.Marton, i.G.Martin, m.J.Mcmahon citation: surg endosc (1995); 9:1274-1278.Laparoscopic cholecystectomy (lc) is now the treatment of choice for gallstones, but there has been concern that bile leakage with lc is more frequent than after open cholecystectomy (oc).The authors analyzed their experience of this complication with regard to both its incidence and management.This study involves 500 patients (age range: 19-89 years) who underwent laparoscopic cholecystectomy between june 1990 and november 1994.The cystic duct was occluded with absolok absorbable polidyoxanone locking clip (ethicon), endoloop chromic catgut (ethicon) and vicyl suture (ethicon).Reported complications included: patient 8, male patient, was readmitted with a right subphrenic collection which was treated with ultrasound-guided drainage.Ercp showed a cystic duct stump leak which was treated by endoscopic stenting.The bile leak rapidly ceased, and the stent was removed uneventfully 3 months later.In conclusion, the data support the view that bile leakage occurs more commonly after laparoscopic than after conventional cholecystectomy.The reason for the difference is unclear, as is the source of bile leakage in most patients.It is the author¿s contention that the increased frequency of bile leakage creates a greater priority for routine drainage of the subhepatic space after laparoscopic cholecystectomy.

• Brand Name: ENDOLOOP LIGATURE UNKNOWN PRODUCT
• Type of Device: CANNULA, SURGICAL, GENERAL AND 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: 8520196
• MDR Text Key: 142194300
• Report Number: 2210968-2019-80412
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• 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: 03/20/2019
• 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