MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETS ARTIC LNR CUTR NO KNIFE; STAPLE, IMPLANTABLE

Model Number	ATS45NK
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Codes	Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Obstruction/Occlusion (2422)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.(b)(4).Date of event is 2020, event day and month unknown.Captured as (b)(6) 2020.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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 or Problem Description
It was reported that the patient with appendicitis underwent a laparoscopic appendectomy at cedars-sinai medical center.Medical records provided indicate that a ¿blue load cartridge endo stapler¿ was used to transect the appendix at the base, and two white loads were used to staple across the mesentery.A clip was placed to achieve hemostasis at the staple lines.The patient was discharged the next day with no issues.The patient returned to the hospital on pod 5 with nausea but was discharged and returned again on pod 7 with nausea, vomiting, and crampy abdominal pain.Her labs were notable for leukocytosis, and her ct scan was concerning for high grade small bowel obstruction.The patient thus underwent an exploratory laparotomy during which the surgeon noted ¿a focal point of obstruction was noted to be from a loose staple from the prior endo-stapler used for her appendectomy, which caused an adhesion from a portion of the small bowel to mesentery.¿ the staple was removed and another like it was also removed.The prior appendectomy site was noted to be intact.The patient was discharged on pod 13 in stable condition after having her diet slowly advanced and ng tube removed.Eight months later, the patient experienced acute onset abdominal pain.A ct confirmed a closed loop bowel obstruction, and patient underwent a small bowel resection with primary anastomosis the same day.The op note further indicates that a loop of bowel appeared necrotic, and the decision was made to convert the surgery to a laparotomy.The adhesive band causing the obstruction was released, and the necrotic portion of the bowel was divided and 68 cm of bowel was resected.The bowel was reanastomosed in a side-to-side fashion.No complications were noted.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/15/2022.Additional information: see attached medical records.

• Brand Name: ETS ARTIC LNR CUTR NO KNIFE
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo
• MDR Report Key: 14480310
• Report Number: 3005075853-2022-03306
• Device Sequence Number: 4808851
• Product Code: GDW
• UDI-Device Identifier: 10705036001089
• UDI-Public: 10705036001089
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: ATS45NK
• Device Catalogue Number: ATS45NK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECR45W
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 65 KG