MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON*45 ENDOPATH** STAPLER ENDOSCOPIC LINEAR CUTTER RELOADS; STAPLE, IMPLANTABLE

Catalog Number ECR45B

Device Problem Defective Component (2292)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # n53d23.Additional information requested but unavailable: can you please clarify how the "recharge was defective during stapling?" what was the product code of the stapler being used with the ecr45b (long45a, ec45a, ple45a, etc.)? how was the procedure completed? the box was checked on the complaint form that it required intervention to prevent permanent impairment or damage.Was this box checked in error? was there any patient consequence or change in the post-operative care of the patient as a result of the event? the analysis result that one ecr45b reload was received with the pan damaged.As the cartridge pan was noted to be damaged and bent; it is possible that the cartridge was not properly loaded on the device, causing the damaged to the pan.No functional test was performed due to the condition of the cartridge.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meets the required specifications prior to shipment.The device history records were reviewed and the manufacturing criteria were met prior to the release of this batch/lot.

Event Description

It was reported that during a gastroplasty procedure, the surgeon communicates that during the procedure the recharge was defective during stapling.Unknown how case was completed.Required intervention to prevent permanent impairment or damage.

• 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: 6026390
• MDR Text Key: 57336156
• Report Number: 3005075853-2016-05880
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 08/16/2016

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: 01/31/2021
• Device Catalogue Number: ECR45B
• Device Lot Number: N4L543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1