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

Catalog Number ECR60D

Device Problems Crack (1135); Mechanical Problem (1384); Failure to Form Staple (2579); Failure to Fire (2610)

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

Event Date 09/24/2014

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic sleeve gastrectomy procedure, the surgeon uses two guns per case and seamguard on all reloads.The first two reloads were black.On the third firing (second firing of the first gun), a gold reload misfired on the specimen side.The outer row of staples appear to have formed properly while the two inner rows formed sporadically and intermittently, and several staples remained in their pockets with staple legs exposed.Furthermore, the first few staple pockets appear to be crumpled with the staples partially formed.And at that same point the inside of the knife channel is deformed or cracked.The original two guns were used with subsequent reloads without incident.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Information anticipated, but unavailable at this time.Additional information was requested and the following was obtained: what color cartridges were used after this event? gold (w seamguard).What was the product code and lot/batch number for the stapler used with the ecr60d.Cartridge (ex, ec60, long60a, pse60a, etc)? ple60a unknown lot number.What was the patients bmi and gender? unknown.

Manufacturer Narrative

(b)(4).Additional information: the analysis found that one ecr60d cartridge reload was received for analysis and cartridge body was noted to be damaged.The reload was received with the right side outer row partially fired 1/2, left side fully fired and the left two inner rows partially fired 1/3.Upon evaluation of the reload, the cartridge body, one piece sled and some drivers were noted to be damaged.No obvious damage to the cartridge deck was noted, which suggests the cartridge, may not have been fired over a hard object.Additionally the cartridge pan was noted to be partially dislodged at left distal end.No functional test could be performed due to the condition of the reload.The batch record was reviewed and no anomalies were noted during the manufacturing process.

• Brand Name: ECHELON 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): DEFAULT ORGANIZATION; 4545 creek rd ml # 36; cincinnati OH 45242 280
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4174278
• MDR Text Key: 16547036
• Report Number: 3005075853-2014-07105
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110385
• 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: 09/24/2014

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: 04/19/2019
• Device Catalogue Number: ECR60D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 10/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2014
• 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
• Treatment: RELOAD - ECR60D