MAUDE Adverse Event Report: ETHICON ENDO SURGERY, INC (CINCINNATI) ECHELON LINEAR CUTTER; STAPLE, IMPLANTABLE

Catalog Number EC60XX

Device Problem Defective Component (2292)

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

Event Date 09/24/2014

Event Type  malfunction  

Event Description

Please see the user facility medwatch, #(b)(4), attached to this report.

Manufacturer Narrative

(b)(4).Information was not provided by the initial contact.Information is unavailable.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.At the time of this submission, the device has not been returned for analysis.The following information was requested, but unavailable: please clarify the product code? do you have a batch or lot#? was the cutline and staple line equal in length? was the device able to be opened and removed from the patient? or was the device cut off the tissue with a second device? was there any patient consequence?.

• Brand Name: ECHELON LINEAR CUTTER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO SURGERY, INC (CINCINNATI); 4545 creek rd; cincinnati OH 45242 280
• Manufacturer (Section G): ETHICON ENDO SURGERY, INC. (TORRES); avenida de las torres 7125 par; que; ciudad juarez, chihuahua ; MX
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4706402
• MDR Text Key: 5667223
• Report Number: 1527736-2015-00008
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• PMA/PMN Number: K051002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Type of Report: Initial
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC60XX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention