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

Catalog Number PLE60A

Device Problems Component Falling (1105); Crack (1135)

Patient Problem Foreign body, removal of (2365)

Event Date 11/13/2014

Event Type  malfunction  

Event Description

It was reported that during a sleeve gastrectomy procedure, on the last firing of the sleeve the reload cracked and parts of the driver came off in the patient.We did the leak test and sleeve tested fine, no leaks.The three pieces of orange "driver plastic" were removed from the abdomen prior to closing the patient.Upon examining the remnant stomach that was resected, it was noted the disrupted staple line was on the remnant stomach vs patient side.Seamguard buttressing was used.This was the last firing so the case was complete.

Manufacturer Narrative

(b)(4).Information is unavailable.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.At the time of this submission, the device has not been returned for analysis.Additional information was requested and the following was obtained: per the sales rep: upon examining the remnant stomach that was resected, we noted the disrupted staple line was on the remnant stomach vs patient side.It appeared that the physician crossed multiple staple lines also through excess seam guard buttressing.It appears that this may be what caused the break in the cartridge.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What was the product code of the cartridge used in the procedure? what color cartridges were used prior to this firing? what was the patient¿s bmi and gender? what was meant by ¿disrupted staple line¿? were the staples malformed? was the staple line incomplete (missing staples along the staple lines)?.

Manufacturer Narrative

(b)(4).Additional information: cartridge, one piece sled, drivers.Additional information was requested and the following was obtained: what was the product code of the cartridge used in the procedure? ecr60b what color cartridges were used prior to this firing? 6 firings prior to this cartridge breaking.All other fires had gore seamguard, this was a plain blue for last firing of sleeve gastrectomy over fundus.What was the patients bmi and gender? not sure of gender/bmi.What was meant by disrupted staple line? malformed staples, many jumbled over each other.It appears that the last firing went across multiple staple lines in the gore seamguard and possibly one of the staples got lodged under the knife blade?? the analysis found that one ple60a device was returned in good visual condition and with an ecr60g cartridge reload present.Additionally, the reload was received with the left side fully fired, right side outer row 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.As additional testing, the device was tested for functionality in the straight 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.However, the cut was noted to be jagged due to a damaged knife.One possible cause for this type of damage to the knife is when the device is fired over an already existing staple line, hard object or thicker tissue than indicated.Repeatedly firing across existing staple lines can also reduce the ability to cut cleanly.To mitigate the potential for staples getting into the cartridge and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and cartridge jaw in sterile solution and then wipe the anvil and cartridge jaw to clean any formed but unused staples from the device.Additionally, proper care should be taken when placing the device on the tissue to be stapled, to ensure that no hard obstruction such as a clip is included with the tissue inside the jaws.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 batch record was reviewed and no anomalies were noted during the manufacturing process.

• Brand Name: ECHELON LINEAR CUTTER
• 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: 4290742
• MDR Text Key: 5271577
• Report Number: 3005075853-2014-08260
• 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: 11/14/2014

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: 09/15/2017
• Device Catalogue Number: PLE60A
• Device Lot Number: L92N8U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 12/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2014
• 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