MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 75 MM NTLC SELECTABLE RELOAD; STAPLE, IMPLANTABLE

Model Number SR75

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t5ck1a.Additional information was requested but not available: were there any patient consequences reported? if yes please describe.Can you please clarify the event of ¿no knife advancement¿? did the device deliver any staples? if yes, was the staple line complete? did the device cut? if yes, was the cut line complete? was there any difficulty opening the device? if yes, how was the device removed from the patient? device analysis: the analysis found that one sr75 reload was returned with no apparent damage.The reload was received with the knife not completely within the doghouse, the proximal 39 drivers up, the remaining drivers were down with staples present, and the swing tab was in the unlocked position.The cartridge was tested for functionality with a test device and fired without any difficulties.The staple line and cut line were complete and the staples met the staple form release criteria.The swing tab in unlocked position is consistent with an improper loading technique.A probable cause for the reported incident is that the device may have been partially fired, causing the lockout to be set.It is possible that the knife exposure on the reload is consist with the firing knob not being returned completely prior to opening the device, causing the knife to not returned completely to its home position.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.

Event Description

It was reported that during an unknown procedure, there was no knife advancement as soon as cartridge was installed.It's unknown whether there were any patient consequences.No additional information is available at this time.

• Brand Name: 75 MM NTLC SELECTABLE RELOAD
• Type of Device: 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 9916038
• MDR Text Key: 198920744
• Report Number: 3005075853-2020-01944
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036002833
• UDI-Public: 10705036002833
• Combination Product (y/n): N
• PMA/PMN Number: K092577
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: SR75
• Device Catalogue Number: SR75
• Device Lot Number: T40H7Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1