MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETS FLEX ARTICNG; STAPLE, IMPLANTABLE

Catalog Number ATS45

Device Problems Cut In Material (2454); Failure to Fire (2610)

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

Event Date 03/04/2014

Event Type  malfunction  

Event Description

It was reported that during a donor nephrectomy procedure the device cut.There were two staple lines that were missing.There was a blood loss 300cc.There was no blood transfusion required.The patient was fine after the procedure was completed.

Manufacturer Narrative

(b)(4).Information anticipated, but unavailable at this time.

Manufacturer Narrative

(b)(4).The analysis results found that the ats45 device was returned in good visual condition and with no reload present on the device.The device was tested for functionality with a test reload and it fired, cut and formed the staples as intended.The device fired without any difficulties, the staple line was complete, the cut line was complete and the staples were noted to have the proper b-formed shape.Event could not be confirmed as no cartridge was received for analysis.The batch record was reviewed and no anomalies were noted during the manufacturing process.

• Brand Name: ETS FLEX ARTICNG
• 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: 3724549
• MDR Text Key: 4329585
• Report Number: 3005075853-2014-02240
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2018
• Device Catalogue Number: ATS45
• Device Lot Number: K4DL1X
• Other Device ID Number: BATCH # K5E71T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2013
• 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