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

Catalog Number ERXXX

Device Problem Insufficient Information (3190)

Patient Problems Anemia (1706); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The lot/batch was not provided; therefore, the manufacturing records 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.Does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.

Event Description

Title: vascular stapler for transection of pancreatic parenchyma in laparoscopic distal pancreatectomy.Authors: samir j.Sahay, m.B.B.S., m.S., panagis m.Lykoudis, m.D., msc., amar al midani, m.D., adam haswell, m.B.B.S., sakhawat h.Rahman, m.D.Citation: the american surgeon, vol.85, june 2019, e275-e276.This single-center prospective study aimed to present laparoscopic distal pancreatectomy with the use of endoscopic vascular stapler alone for pancreatic transection, with particular focus in pancreatic fistula (pf) development and relevant postoperative outcomes.A total of 43 consecutive patients (n=9 male, n=34 females, median bmi: 27 kg/m2, bmi range: 24-34) who underwent ldp for treatment of lesions in the body or tail of pancreas were included.Lesser omental sac was accessed using harmonic scalpel (harmonic ace) (ethicon).In spleen-sparing procedures, splenic vessels were dissected from the posterior pancreatic surface and small tributaries were divided either with harmonic scalpel or with endoscopic clips (ligaclip) (ethicon), while splenic artery was divided either between hemolocks or with the use of endoscopic vascular stapler (endopath ets-flex 45 mm/2.5 mm) (ethicon).Pancreas was transected with endoscopic vascular stapler as well (endopath ets-flex 45 mm/2.5 mm) (ethicon) without any adjunct.Dissection of surgical specimen was completed using harmonic scalpel (ethicon).Complaints included intra-abdominal collections (n=12); increased inflammatory markers (n=10) where two had ultrasound-guided drainage indicated because of persistently increased inflammatory markers with the drain fluid amylase (dfa) being similar to that of serum; decreased hemoglobin (n=1); small collections (<3 cm) without evidence of infection (n=6) and were managed conservatively without any deviation from routine postoperative care; bleeding (n=1) and returned to theater; and grade c postoperative pancreatic fistula (pf) (n=2).The results of this study presented that the use of vascular stapler alone is associated with a lower pf rate compared with that reported in the literature.

• Type of Device: CLIP, IMPLANTABLE
• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10273626
• MDR Text Key: 202057320
• Report Number: 3005075853-2020-03566
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ERXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention