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

Catalog Number	ECXXX
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Hemorrhage/Bleeding (1888); Perforation (2001); Peritonitis (2252)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Publication year of 2020.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.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?.
Event or Problem Description
It was reported via journal article title: impact of resection volume/stapler firings-ratio on perioperative complications and weight loss after laparoscopic sleeve gastrectomy authors: andrea della penna, jessica lange, rami archid, felix hones, alfred konigsrainer, markus quante.Citation:obesity surgery (2021) 31:207¿214 https://doi.Org/10.1007/s11695-020-04870-0.The objectives of this study was to hypothesize the surgical technique as reflected by the number of stapler firings and the grv will impact both postoperative complications and 12- month weight loss results after lsg.A retrospective analysis of our prospectively collected database of all patients undergoing bariatric procedures at the university hospital of tübingen, germany, between january 2007 and november 2017 was performed.Patients undergoing combined bariatric procedures and other stand-alone surgical or endoscopic procedures besides lsg were excluded.A gastric tube was positioned along the minor gastric curvature, and the gastric sleeve was performed along the bougie using a 60-mm ethicon echelon stapler (ethicon endo-surgery inc., cincinnati, oh).A total number of 384 patients had complete clinical follow-up at 12 months after the surgical procedure and were thus selected for final analysis.Median age of our patients at time of surgery was 43 years(range 18¿68); 95 patients (24.7%) were male, and 289 patients (75.3%) were female.Reported complications included staple line leaks occurred (n=7), perforation (n=5), diffuse peritonitis in the early postoperative course (n=2), postoperative bleeding (n=6).In conclusion grv/ stapler firings-ratio might serve as a simple predictive factor to identify patients at risk for postoperative complications and impaired weight loss.

• Brand Name: ECHELON ENDOPATH STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 12269162
• Report Number: 3005075853-2021-04377
• Device Sequence Number: 3869455
• Product Code: GDW
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 07/05/2021

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 Catalogue Number: ECXXX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 08/03/2021
• Patient Sequence Number: 1