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

Catalog Number	EL414
Health Effect - Clinical Codes	Failure to Anastomose (1028); Fistula (1862); Ischemia (1942); No Code Available (3191)
Date of Event	06/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.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.What is the serial number of the el414 device? what is the age of the el414 device? were the tips of the el414 device inspected for proper alignment prior to the procedure? was the lc800 base used with the lt400 clip cartridge? can you please describe the clip formation in more detail? was this issue identified intra-operatively or post-op? how many clips were placed? how many clips were observed to be ¿loose¿? what is the lot number for the lt400? what is the current patient status?.
Event or Problem Description
It was reported that patient with acute pancreatitis, hospitalized on (b)(6) 2019, underwent laparoscopic surgery converted to laparotomy with bileodigestive derivation (hepaticojejunostomy in y-de-roux).Clips applied in the ligation of the biliary tract were loosen.Preoperative diagnosis: biliary fistula.Postoperative diagnosis: loosening of the cystic duct ligature + partial ischemia of the colédoco and hepatic duct.Intercurrent: conversion to open surgery.Description of the surgery: patient in dorsal decubitus under general anesthesia.Antisepsis and placement of sterile fields.Withdrawal of the stitches of the previous surgery and pneumoperitoneum done by the umbilical incision by open technique.Cavity review: small amount of free biliary secretion in hypochondrium d, intense inflammatory block in hcd.The blockage was disassembled with extreme caution with visualization of loosening of the cystic ligation clip, partial ischemia of the common bile duct and hepatic duct approximately 20 mm proximal and distal to the local of the loosen clip, intense local inflammatory process.Due to the impossibility of continuing the procedure by laparoscopy, it was decided to convert to open surgery.Kocher's right subcostal incision and opening by planes.Performing an enterotomy in the alimentary loop at 60 cm of the previous gastrojejunoanastomosis (roux-en-y gastric bypass surgery), closing of orifices with pds 3-0.Accomplishment of lateral-lateral enteroanastomosis, at 50cm of the enterotomy, mechanical (1 load stapler linear cortant) + closure of the orifice in 2 planes with prolene 2-0.Catheterization of the bile duct with intracath catheter - patency test of the proximal bile duct with reflux of biliary secretion.Ligature of the distal portion of the common bile duct.Performing termino-lateral hepaticojejunostomy in roux-y points separated from vicryl 4-0.Preparation of anchorage suture between jejunal loop and hepatic parenchyma with vicryl stitches 3-0 cavity review and hemostasis.Placement of tubulo-laminar drain and withdrawal by counter-incision.Suture of aponeurosis with vicryl 1 and skin with nylon 3.0.Fixing the drain with mononylon.Infiltration of aponeurosis with ropivacaine + xylocaine.Sterile dressing.Wires used and high-cost materials 03 vicryl 1/01 cotton 2.0 / 03 nyl n 3.0 / 10 vicryl 4-0 / 2 vicryl 3-0 / 1 pds 3-0 / 1 prolene 2-0 / 1 linear shear stapler.
Additional Manufacturer Narrative
(b)(4).Corrected data - (catalog) will be viewed as el414.(concomitant med products) will be viewed as lt400.
Additional Manufacturer Narrative
(b)(4).Device analysis: the analysis results found that the el414 device was received with no apparent damage.In an attempt to replicate the reported incident, the device was tested for functionality.Upon functional testing of the device, the instrument loaded, retained and deployed 6 clips as intended.The instrument was fully functional and conforming.The event described could not be confirmed as the device performed without any difficulties noted.The batch history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.  the certificate records are accessible through external manufacturing. .

• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8804490
• Report Number: 3005075853-2019-20480
• Device Sequence Number: 1658512
• Product Code: HBT
• UDI-Device Identifier: 10705036012832
• UDI-Public: 10705036012832
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K830503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EL414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 07/26/2019; 08/22/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 08/15/2019; 08/23/2019
• Patient Sequence Number: 1
• Patient Age: 29 YR