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

Catalog Number EC45A

Device Problems Defective Component (2292); Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

It was reported that during an unknown procedure, there was an issue with a defective endocutter.The gun will not open its jaws and is jammed shut.The event was managed by opening a new device to continue the procedure.There was no harm or injury to the patient and the case was not impacted longer than thirty minutes.

Manufacturer Narrative

(b)(4).Batch # n54z34.The analysis found that one ec45a device was returned with no apparent damage and with one ecr45b cartridge loaded in the device.The cartridge reload was received fully fired and in good visual condition.The device was tested for functionality in the articulated position with a test cartridge reload and achieved its complete 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.Event could not be confirmed as the device opened and closed without any difficulties noted.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: ECHELON ENDO LINEAR CUTTERS
• 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: 6173373
• MDR Text Key: 62682015
• Report Number: 3005075853-2016-07011
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K051002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2016

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: 04/28/2019
• Device Catalogue Number: EC45A
• Device Lot Number: N91M9A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2016
• 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