MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL GENERIC PRODUCT CODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number NSEALXXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fistula (1862); Insufficient Information (4580)

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2021.Batch # unk.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.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 author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.Additional information was obtained: 30 day mortality (n=1) occurred in the open surgery group.However, uses of energy devices were only mentioned in minimal invasive surgery group (either robotic or laparoscopic).From available information, this patient death also had nothing to do with use of energy devices.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: short- and long-term outcomes after minimally invasive versus open spleen-saving distal pancreatectomies.Authors: madeline chee, chuan-yaw lee, ser-yee lee, london l.P.J.Ooi, alexander y.F.Chung, chung-yip chan, brian k.P.Goh.Citation cite: doi:10.4103/jmas.Jmas_178_20.This study aimed to compare the perioperative outcomes of patients who underwent minimally invasive spleen-preserving distal pancreatectomy (mi-spdp) versus open surgery spdp (o-spdp).It also aimed to determine the long-term vascular patency after spleen-saving vessel-preserving distal pancreatectomies (ssvdps).A retrospective review of 74 patients who underwent successful spdp and met the study criteria was performed.Of these, 67 (90.5%) patients underwent ssvdp, of which 38 patients (21 open, 17 mis) had adequate long-term post-operative follow-up imaging to determine vascular patency.Fifty-one patients underwent open spdp, whereas 23 patients underwent minimally invasive spdp, out of which 10 (43.5%) were laparoscopic and 13 (56.5%) were robotic.Harmonic scalpel (ethicon), enseal (ethicon).Reported complications included pancreatic fistula (n=11 ), reoperation (n=3), readmission (n=11 ), 30 day mortality (n=1).Splenic perfusion, splenic artery patency.In conclusion adoption of mi-spleen-preserving distal pancreatectomy (spdp) is safe and feasible.Mi-spdp is associated with a shorter hospital stay, lower blood loss but longer operation time compared to o-spdp.In the present study, mi-ssvdp was associated with poorer long-term splenic vein patency rates compared to o-ssvdp.

• Brand Name: ENSEAL GENERIC PRODUCT CODE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15462544
• MDR Text Key: 300362529
• Report Number: 3005075853-2022-06303
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K072177
• 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
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NSEALXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention