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

Catalog Number TL90

Device Problems Crack (1135); Material Too Rigid or Stiff (1544); Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information was not provided by the contact.Batch # m53k9v.Damaged adjusting knob, lockout slide tip damaged.Three attempts were made to obtain additional information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.When the plastic casing cracked, did any pieces fall into the patient? if yes, were all pieces retrieved? will all pieces be returned with the device? if no, how were they discarded? the analysis results showed that the tl90 device was received in good visual conditions and with cartridge present on the device.The cartridge was returned fully loaded with staples.The device was tested for functionality with returned cartridge and it forms 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.The batch record was reviewed and no anomalies were noted during the manufacturing process.

Event Description

It was reported that during a right hemicolectomy procedure, the surgeon placed the stapler on the bowel, the retaining pin was put into position.The compression knob was very stiff and would not turn.The surgeon forced the knob to turn, and the plastic casing close to the knob cracked and opened.Another like device was used to complete the procedure.There was a delay of two minutes.There were no adverse consequences for the patient reported.

• Brand Name: PROXIMATE RELOADABLE LINEAR STAPLER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5051672
• MDR Text Key: 25534355
• Report Number: 3005075853-2015-05532
• 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: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/16/2015

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: 04/06/2020
• Device Catalogue Number: TL90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2015
• 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