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 Hematoma (1884); 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 batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Citation: the heart surgery forum #2004-1049 7 (5), 2004 [epub september 2004].Doi:10.1532/hsf98.20041049.(b)(4).

Event Description

It was reported via journal article "title: endoscopic radial artery harvest for coronary artery bypass grafting: initial clinical experience" authors: oz m.Shapira, benjamin eskenazi, richard murphy, elad anter, yusheng bao, harold l.Lazar, richard j.Shemin, curtis t.Hunter citation: the heart surgery forum #2004-1049 7 (5), 2004 [epub september 2004].Doi:10.1532/hsf98.20041049.The aim of this study was to evaluate the initial clinical experience with the endoscopic technique to harvest the radial artery (ra) via a 3-cm wrist incision in patients undergoing coronary artery bypass graft (cabg).This prospective study involves 75 consecutive patients (66 male and 9 female; average age: 60±9 years; age range: 31-77 years) undergoing cabg with endoscopic ra harvest using the ultra-retractor (cardiovations; ethicon) and the harmonic scalpel (ethicon) between december 2002 and january 2004.During the radial artery harvest, a 3-cm longitudinal skin incision starting 1 cm proximal to the radial styloid was performed.The radial artery was dissected as a pedicle with its accompanying veins and fat.The ultra- retractor (cardiovations; ethicon) was then introduced and video-assisted dissection of the radial artery pedicle was performed with a 30° scope using the harmonic scalpel (ultracision harmonic scalpel; ethicon).By advancing the ultra-retractor 1 cm at a time and controlling the branches with the harmonic scalpel, care was taken to avoid avulsion of branches.Thermal damage to the radial artery was avoided by keeping the active blade of the harmonic scalpel away from the radial artery during coagulation of branches or tissue dissection.The dissection extended proximally to just distally to the brachial artery bifurcation.Proximal control of the radial artery was achieved with an endo-loop ligature (ethicon).The artery was divided with an endo-scissors (ethicon), gently flushed with heparinized plasma-lyte solution and stored in a papeverine basin.Reported complication included tunnel hematoma (n-1) which required re-exploration of the arm to evacuate the tunnel hematoma, transient mild dorsal thenar numbness or paresthesias (n-63) which subsided within 2 to weeks postoperatively in most cases, severe sensory symptoms in the superficial radial nerve territory (n-1), and damage to the conduit (n-1).In conclusion, short-term results of endoscopic ra harvest are excellent.There is a significant learning curve.Long term follow-up as well as structural and functional assessments of the conduit are indicated.

• Brand Name: ENDOLOOP LIGATURE UNKNOWN PRODUCT
• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9281211
• MDR Text Key: 165243183
• Report Number: 2210968-2019-89546
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2019
• 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