MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LINEAR CUTTER RELOAD; STAPLE, IMPLANTABLE

Catalog Number ECR60D

Device Problem Failure to Discharge (1169)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2015

Event Type  malfunction  

Event Description

It was reported that during a colon procedure, the staples will not release.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).If the device cut, was the cut line complete? no response.The analysis results showed that one ecr60d cartridge reload was received unfired and in good visual conditions.In addition a cartridge pan was found lodged on the received cartridge reload.The dislodged pan was removed and the returned reload was loaded into a test ec60a device.The device was tested for functionality in the articulated position and achieved its complete stroke firing sequence without any difficulties.The staple line and cut line were complete and the staples were noted to have the proper b-form shape.While no conclusion could be reached as to how the pan became dislodged from the reload, it should be noted that a 100% inspections takes place during manufacturing to ensure the device meets the required specifications.The batch record was reviewed and no anomalies were noted during the manufacturing process.

• Brand Name: LINEAR CUTTER RELOAD
• 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4587155
• MDR Text Key: 15960544
• Report Number: 3005075853-2015-01619
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051002
• 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: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2019
• Device Catalogue Number: ECR60D
• Device Lot Number: L4FC4F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1