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

Model Number	TCR10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a gastrectomy procedure the staplers led to bleeding after firing.There was internal bleeding in the gastrectomy case after the device was stapled.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/13/2023.D4: batch#: unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.Additional information was requested, and the following was obtained: 1.Was there any other issue noted with the staple line other than bleeding/oozing (malformed staples, staple line missing staples, etc.)? no.2.How was the bleeding controlled? post surgery blood was infused in patient.3.How much blood was lost (ml)? 2 bottles he mentioned.4.Did the patient require a transfusion? unknown.5.Could you please clarify if there were any patient consequences? blood loss.6.Could you please clarify if was any change in the post-operative care of the patient as a result of the event? unknown.What were the indications for surgery? cancer at gastro.What surgical procedure was performed? partial gastrectomy.Did the patient receive any preoperative chemotherapy or radiation? unknown.Were there any issues experienced with the device in the surgical procedure? no.How was the bleeding identified? bleeding seen during surgery on anastomosis.How long after the initial procedure did the bleeding occur? unknown.How was the bleeding addressed? doctors put wet gauze.What was the pre and postoperative anti-coagulant and pain management protocol? unknown.Was the bleeding intraluminal or extraluminal? intraluminal.Were there any issues noted with staple formation? if so, please describe the shape and location.Unknown.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.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17117897
• Report Number: 3005075853-2023-04041
• Device Sequence Number: 7039046
• Product Code: GDW
• UDI-Device Identifier: 10705036003045
• UDI-Public: 10705036003045
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2023

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 Model Number: TCR10
• Device Catalogue Number: TCR10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/13/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female