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

Model Number	SDH25A
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.
Event or Problem Description
It was reported that during the endoscopic esophagectomy, when severing esophageal and gastric tissues, after fired, noted some staples malformed.Used suture to oversew.There was no patient consequence reported.No additional information can be provided.

• Brand Name: ILS 25MM, STRAIGHT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 10206003
• Report Number: 3005075853-2020-03236
• Device Sequence Number: 2405197
• Product Code: GDW
• UDI-Device Identifier: 10705036003526
• UDI-Public: 10705036003526
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: SDH25A
• Device Catalogue Number: SDH25A
• Device Lot Number: N4L968
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 06/29/2020
• Patient Sequence Number: 1