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

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

Patient Problems Hemorrhage/Bleeding (1888); Inflammation (1932)

Event Date 04/03/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? 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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2021-09743.Citation: surgical endoscopy (2021) 35:437¿448 https://doi.Org/10.1007/s00464-020-07522-7.

Event Description

Title: transductal versus transcystic laparoscopic common bile duct exploration: an institutional review of over four hundred cases the aim of this study was to report outcomes of transcystic versus transductal laparoscopic common bile duct exploration (lcbde) from our experience of over four hundred cases.Retrospective review of 416 consecutive patients who underwent lcbde at a single-centre between 1998 and 2018 was performed.Transductal lcbde via choledochotomy was achieved in 242 patients (58.2%), whereas 174 patients (41.8%) underwent transcystic lcbde.Stone clearance rates, conversion to open surgery were similar between the two groups.Overall morbidity as well as minor and major post-operative complications were significantly higher in the transductal group.The cranial end of the incision and closing the incision primarily using continuous 5¿0 vicryl(ethicon) on a curved cutting needle starting from the caudal end.The proximal cystic duct was then retracted by an endoloop (ethicon).Reported complications included clavien¿dindo i¿ii, clavien¿dindo iii¿iv, bile leak, pancreatitis, bleeding.In conclusion this study represents the largest single study to date comparing outcomes from transcystic and transductal lcbde.Where possibly, the transcystic route should be used for lcbde and this approach can be augmented with various techniques to increase successful stone clearance and reduce the need for choledochotomy.

• Brand Name: ENDOLOOP LIGATURE UNKNOWN PRODUCT
• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• 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
• MDR Report Key: 12638406
• MDR Text Key: 281155081
• Report Number: 2210968-2021-09744
• 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,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 01/10/2022
• Supplement Dates FDA Received: 02/03/2022
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention