MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*55MM LINEAR CUTTER; STAPLE, IMPLANTABLE

Model Number	TLC55
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	04/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unknown.Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.Additional information was requested, and the following was received: was there any medical or surgical intervention provided to the patient during their observation time at the hospital? no.Was there any diagnostic testing done? unknown.That is all the information i have regarding this event.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 in a left colectomy on april sixth, case proceeded uneventfully.No challenges intraoperatively.Postoperatively, the patient developed bloody bowel, significant hematocrit drop, intra-abdominal and intraluminal bleeding.The patient was readmitted for observation.No other intervention, no transfusion and the patient is home now.The tlc55 was used to transect the bowel and complete the anastomosis.Tx60b was also used to close the colostomy.No other information is available.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 11913230
• Report Number: 3005075853-2021-03019
• Device Sequence Number: 11086834
• Product Code: GDW
• UDI-Device Identifier: 10705036013204
• UDI-Public: 10705036013204
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2021

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: TLC55
• Device Catalogue Number: TLC55
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/01/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TCR55
• Outcome Attributed to Adverse Event: Hospitalization