MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. RELOADS FOR LINEAR CUTTERS; STAPLER, IMPLANTABLE

Catalog Number 6R45B

Device Problems Defective Component (2292); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device analysis: the analysis results found that one 6r45b reload was received with no apparent damaged and partially fired 1/10 which indicates that the device's firing cycle was interrupted.When firing the device make sure that the firing stroke is completed.Do not partially fire the device.Fire the device by squeezing the firing trigger completely until it rests on the closing trigger.Once the firing cycle has been initiated, it must be completed.If re-initiation of firing is resumed, the device will lockout.Firing through the lockout mechanism will break the device.Please reference the instruction for use for more information.No functional test could be performed due to the condition of the reload.The batch history record was reviewed and no protocols or ncrs related to the complaint were found during the manufacturing process.

Event Description

It was reported that during a laparoscopic appendectomy "the load is defective, would not fire".The procedure was completed with an alternate like device with no patient consequences reported.There is no additional information.

• Brand Name: RELOADS FOR LINEAR CUTTERS
• Type of Device: STAPLER, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7435953
• MDR Text Key: 105932815
• Report Number: 3005075853-2018-09182
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20705036000843
• UDI-Public: 20705036000843
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2022
• Device Catalogue Number: 6R45B
• Device Lot Number: P4T49A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1