MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON 60 ENDOPATH STAPLER; STAPLE, IMPLANTABLE

Model Number	EC60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fever (1858); Hemorrhage/Blood Loss/Bleeding (1888); Nausea (1970); Abdominal Distention (2601); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.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 devices mentioned in this article caused/contributed to the reported events in the article? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported via journal article title: resection of the gastric submucosal tumor (g-smt) originating from the muscularis propria layer: comparison of efficacy, patients¿ tolerability, and clinical outcomes between endoscopic full-thickness resection and surgical resection authors: sha liu, xinxin zhou, yongxing yao, keda shi, mosang yu, feng ji citation: surgical endoscopy (2020); 34: 4053¿4064.Doi: https://doi.Org/10.1007/s00464-019-07311-x the aim of this retrospective study is to compare the efficacy, tolerability, and clinical outcomes of eftr and surgical intervention for the management of muscularis propria (mp)-derived g-smts.Between september 2011 and may 2019, a total of 62 patients (25 male and 37 female; mean age of 57.35 ± 9.88 years) with primary mp-derived g-smts were enrolled into the endoscopic full-thickness resection (eftr) group (study group).For comparative assessment, a group of 62 patients (24 male and 38 female; mean age of 58.92 ± 9.66 years) with g-smts treated by surgery in the same period was matched for patient baseline characteristics, tumor clinicopathological features as well as the year part of the procedure date.In the surgical resection group, the surgery was performed using linear gastrointestinal stapler(s) (ec60, ethicon).Reported complications included intraoperative bleeding with a mean of 46.97 ± 60.73 ml (n=?); intraoperative bleeding with a mean of 52.50 ± 36.30 ml (n=?) which require blood transfusion in 1 patient; abdominal pain (n=10); abdominal distention (n=6); nausea (n=14); fever (n=18); minor bleeding within 3 days postoperative (n=2) which was successfully stopped by irrigation of norepinephrine and thrombin through the ng tube; esophageal anastomosis stenosis (n=1) which required rehospitalization for endoscopic dilation with savary¿gilliard bougies.In conclusion, in the treatment of mp-derived g-smts (with or without ulceration), our study showed the feasibility and safety of eftr, which also provided better results in terms of procedural blood loss, the postoperative bowel function restoration and cost-effectiveness when compared to surgery, whereas the surgery was superior in en bloc resection rate for g-smts larger than 30 mm.The postprocedural clinical outcomes seemed to be equivalent in these two resection methods.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/10/2021.H1: mdr decision: not reportable.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.Additional information requested and the following was received: does the author/surgeon believe that the ethicon devices mentioned in this article caused/contributed to the reported events in the article? no, they don't believe that.H1: mdr decision: not reportable.

• Brand Name: ECHELON 60 ENDOPATH STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 12256610
• Report Number: 3005075853-2021-04308
• Device Sequence Number: 17358619
• Product Code: GDW
• UDI-Device Identifier: 10705036001690
• UDI-Public: 10705036001690
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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
• Operator of Device: Health Professional
• Device Model Number: EC60
• Device Catalogue Number: EC60
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 08/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention