MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*LINEAR STAP RELOAD; STAPLE, IMPLANTABLE

Model Number	XR60G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Not Applicable (3189)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Only event year known: 2020.Complaint device = unknown.Sterile devices were received on 11/04/2020.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.What was the surgical procedure? how was the leak identified? how was the leak addressed? did the patient undergo any radiation or chemotherapy? what segment of colon was being removed? were any other stapling devices used to create anastomosis? were any issues noted with device during initial procedure? was the device difficult to close or fire? please provide a timeline of events.What was done in the reoperation? what is the current patient status? device analysis of sterile samples: the analysis results showed that the xr60g reloads (a) (b) (c) (d) (e) (f) (g) (h) were received sterile and with no apparent damage.The packages were opened and the reloads were tested for functionality with a test device.The device fired and formed all the staples as intended.The device fired without any difficulties, the staple line was complete, and the staples meet the staple form release criteria.As part of our quality process, the manufacturing records of this batch was reviewed, and the manufacturing standards were met prior to the release of this batch.Although there is no direct evidence of use error, the instructions for use do contain the following caution: make sure tissue to be stapled is properly positioned in the jaws before stapling.Bunching, stretching, or uneven loading of tissue could result in leakage, lack of hemostasis, or disruption of staple line.The event described could not be confirmed as the devices performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch numbers, and no non-conformances 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 after a colon procedure, patient had a leak.Leak was not noticed intra-op.Had to close the bowel.
Additional Manufacturer Narrative
(b)(4).Date sent: 04/06/2021.Additional information was requested and the following was received: the team lead would not give me access to the surgeon.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10792445
• Report Number: 3005075853-2020-05777
• Device Sequence Number: 3657263
• Product Code: GDW
• UDI-Device Identifier: 10705036013471
• UDI-Public: 10705036013471
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: XR60G
• Device Catalogue Number: XR60G
• Device Lot Number: R40Z0R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 04/06/2021
• Patient Sequence Number: 1