MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*75MM LINEAR CUTTER; STAPLE, IMPLANTABLE

Model Number	TLC55
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	11/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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 were the indications for surgery? did the patient receive any preoperative chemotherapy or radiation? what specific bowel procedure was performed? did the issue occur on first firing of each of the devices? if not, what is the scrub¿s experience with loading the device? was there any difficulty loading the device? what color reloads were used and what was the sequence of the firings? what anatomical structures was the device fired on? on which part of the anastomosis creation did the devices jam (proximal/distal transection, creating common channel, etc.)? were other stapling or suturing devices used when creating the anastomosis? was the device difficult to put the two halves together/close? was the device difficult to fire prior to jamming? can more information be provided on the shape and location (proximal to distal or lateral) of the malformed staples? how was the bleeding addressed? how was the anastomosis ultimately completed? was the patient¿s hospital stay extended due to the issues experienced with the devices? what is the current status of the patient? attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Device 3 of 3.
Event or Problem Description
It was reported by the sales rep that during a bowel resection, three staplers, one tlc75 and two tlc55 staplers, produced malformed staples and had excessive bleeding on the staple lines.All 3 staplers allegedly only fired 1/3 of the way and jammed, not allowing the surgeon to continue the complete fire.Surgeon claims the tissue was not too thick or too much tissue along the staple line.The procedure was delayed by an unknown amount of time.It was not reported how the procedure was completed.Unknown how bleeding was controlled.According to the surgeon, hospital stay was extended.To what extent, i don¿t know.Patient was later discharged.Patient is ok.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Date sent: 02/13/2020.Additional information was requested: what were the indications for surgery? did the patient receive any preoperative chemotherapy or radiation? what specific bowel procedure was performed? did the issue occur on first firing of each of the devices? if not, what is the scrub¿s experience with loading the device? was there any difficulty loading the device? what color reloads were used and what was the sequence of the firings? what anatomical structures was the device fired on? on which part of the anastomosis creation did the devices jam (proximal/distal transection, creating common channel, etc.)? were other stapling or suturing devices used when creating the anastomosis? was the device difficult to put the two halves together/close? was the device difficult to fire prior to jamming? can more information be provided on the shape and location (proximal to distal or lateral) of the malformed staples? how was the bleeding addressed? how was the anastomosis ultimately completed? was the patient¿s hospital stay extended due to the issues experienced with the devices? what is the current status of the patient? the following response was obtained: please just look at the device and answer why the reloads misfired 3 times.It was virgin tissue and not very thick.
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent: (b)(6) 2020.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Date sent: 02/13/2020.H11.Corrected data: g4.02/11/2020.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent: (b)(6)2020 d4: batch # t5cy4z device evaluation summary: the analysis results found that the tlc75 device was received with no apparent damaged and with a cartridge reload loaded in the device.The reload had the proximal (b)(4) drivers up without staples, and the remaining drivers down with staples present.The returned reload had the swing tab in the locked position.The reload was reset and the device was tested for functionality with the returned reload and it fired, cut, and formed all the remaining staples as intended.The staple line and cut line were complete and the staples meet the staple form release criteria.It should be noted that the cartridge reload is designed to lockout, as a safety feature, if any staples have been fired from the cartridge reload.In addition, failure to complete the stroke may result in incomplete staple line.For additional information please refer to the instructions for use.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9396840
• Report Number: 3005075853-2019-23893
• Device Sequence Number: 16252907
• Product Code: GDW
• UDI-Device Identifier: 10705036013204
• UDI-Public: 10705036013204
• Combination Product (Y/N): N
• Initial Reporter State: MI
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/11/2019

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: 05/22/2024
• Device Model Number: TLC55
• Device Catalogue Number: TLC75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 12/16/2019; 01/06/2020; 02/11/2020; 02/11/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/02/2020; 01/24/2020; 02/13/2020; 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 55 YR
• Patient Weight: 69