MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 25MM, STRAIGHT; STAPLE, IMPLANTABLE

Catalog Number	SDH25A
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	06/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Additional information was requested and the following was obtained: what were the indications for surgery? colon cancer.What specific surgical procedure was being performed? radical resection of colon cancer.Were there any difficulties experienced with the device in the surgical procedure? no.What healthcare professional fired the device and what is his/her experience with the device? experienced.Where in the green gap setting scale was the indicator located prior to firing (low-b, middle-b, or high-b)? unk.Did the healthcare professional wait 15 seconds after closing the device and then retighten prior to firing? yes.Was a complete transection of the cutting washer visually confirmed during the initial surgical procedure? unk.Were the donuts inspected? if so, please describe.Unk.How was integrity of the anastomosis confirmed intra-operatively? unk.How many days post-op was the bleeding identified? after surgery, noted massive hemorrhage of gastrointestinal tract.How was the bleeding identified? operative exploration of abdomen.What was the total estimated blood loss (ml)? unk.Was a transfusion required? unk.Was the site of the bleeding identified? operative exploration of abdomen.What was observed at the site upon reoperation? pulsatile bleeding at anastomosis.Was staple form able to assessed? if so, please describe.Unk.What is the current status of the patient? stable and left from hospital.Is the device available for analysis? no.
Event or Problem Description
It was reported that following a colon resection, there was bleeding after surgery.During the colorectal surgery, after surgery, noted the patient was bleeding.Did the second surgery, used the suture to oversew.

• Brand Name: ILS 25MM, STRAIGHT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8505712
• Report Number: 3005075853-2019-18000
• Device Sequence Number: 1846719
• Product Code: GDW
• UDI-Device Identifier: 10705036003526
• UDI-Public: 10705036003526
• Combination Product (Y/N): N
• PMA/510(K) Number: K983536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2019

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 Expiration Date: 03/31/2023
• Device Catalogue Number: SDH25A
• Device Lot Number: R40A5Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR