MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE** RELOADABLE LINEAR STAPLER; STAPLE, IMPLANTABLE

Catalog Number TL90

Device Problems Crack (1135); Sticking (1597); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2015

Event Type  malfunction  

Event Description

It was reported that during a reversal ileostomy procedure, a tlc has been used to form the trouser leg on the ileum.The device listed was then to be used to close off the top part of the trouser leg.When the stapler was put into position, the closure knob would not turn.This was the first firing of the stapler out of the packet.It had not been dropped.As far as they could tell, the cartridge was securely in place and there was nothing stopping the knob from turning.The retaining pin had been deployed.The surgeon then tried to force the knob to turn, at which point a loud noise was heard and the plastic frame had cracked.Another like device was used to complete the procedure.There was a delay of three minutes.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4)- adjusting knob, lockout slide tip damaged.Batch # m52r9u.The analysis results showed that the tl90 device was received in good visual conditions and with cartridge present on the device.The device was tested for functionality with a test cartridge and it form the staples as intended and with a proper b formation.The device was disassembled to verify the condition of the internal components and the device was noted to have the lockout tab and the adjusting knob damaged.The damage to the tab and knob is consistent with an excessive force applied to the rotating knob when trying to dial down a locked device, causing the damage to the knob.It should be noted that the instrument has been designed with a lockout feature, which during the first application, prevents turning the adjusting knob unless the retaining pin is pushed completely forward.Please reference the instructions for use for additional information.A batch record review was performed and the batch had no anomalies noted during the manufacturing process.

• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: milton garrett ; 5133378865
• MDR Report Key: 4906743
• MDR Text Key: 6836114
• Report Number: 3005075853-2015-04196
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2015

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: 01/27/2020
• Device Catalogue Number: TL90
• Device Lot Number: M90M3A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2015
• 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