MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETS*45 ENDO LIN CUT RELOAD GR; STAPLE, IMPLANTABLE

Catalog Number	TR45G
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this batch/lot.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.Can you please explain more details? how were the "free cartridges samples received following a tender bid." obtained? were they purchased from an approved distributer in (b)(6)? or, did a sales representative provide these reloads? do you have the packaging and/or additional product that can be returned for analysis? what procedure was performed and what other surgical technique was performed for the closing? is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event (extended hospital stay, readmission, re-operation, etc.)? please explain.
Event or Problem Description
It was reported that during a procedure, use of free cartridges samples received following a tender bid.On the box, it is not indicated to not use the device.The device cut but did not staple (no staples in the cartridge).Several cartridges from different references have been used.Use of another surgical technique to perform the closing.
Additional Manufacturer Narrative
(b)(4).Investigation summary: the analysis results found that one tr45g reload (a) was received fully fired and with no apparent damaged.No functional test was performed due the condition of the returned reload.The analysis results found that one tr45g reload (b) was received sterile and with no apparent damaged.The package was opened and the reload was loaded into a test device and tested for functionality and it fired, cut and formed all the staples as intended.The staple line was complete, and the staples were noted to have the proper b-formed shape.The analysis results found that one tr45g reload (c) was received sterile and with no apparent damaged.The package was opened and the reload was loaded into a test device and tested for functionality and it fired, cut and formed all the staples as intended.The staple line was complete and the staples were noted to have the proper b-formed shape.The event described could not be confirmed as the reload performed without any difficulties noted.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested and the following was obtained: can you please explain more details? how were the "free cartridges samples received following a tender bid." obtained? were they purchased from an approved distributor in (b)(4)? or, did an ethicon sales representative provide these reloads? do you have the packaging and/or additional product that can be returned for analysis? what procedure was performed and what other surgical technique was performed for the closing? is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event (extended hospital stay, readmission, re-operation, etc.)? please explain.Response: can you please explain more details? these sterile samples were provided to the customer for a tender bid.On the packaging, it is indicated "medical sample not to resale".The surgeon used some samples from different products.During their use, the device did not staple as expected but it cut the patient's tissue.Samples received from the last call for tenders by ethicon which started the 1er january 2018.Procedure : exploratory laparotomy.According to the operating theaters, no patient consequence.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7587546
• Report Number: 3005075853-2018-10491
• Device Sequence Number: 13505347
• Product Code: GDW
• UDI-Device Identifier: 20705036003172
• UDI-Public: 20705036003172
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2018

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: 03/27/2022
• Device Catalogue Number: TR45G
• Device Lot Number: P4RL37
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 07/13/2018; 10/25/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 08/09/2018; 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1