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

Catalog Number NTLC75

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590); Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 09/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Information was not provided by the initial contact.Information is unavailable.Batch # m54295.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.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 is the current status of the patient? what were the indications for surgery? what part of bowel was being transected? please explain what is meant by ¿there was a plastic sound?¿ how does the surgeon fire the device (thumb, fingers, palm, etc)? photographic analysis: picture analysis was performed; the picture shows a damaged firing mechanism.The damage to the firing knob is consistent with high (outside indicated use) staple forming forces; however, there is insufficient evidence to determine the cause of the higher loads.It should be noted that the cartridge reload is designed to lockout, as a safety feature, if any staples have been fired from the cartridge reload.If enough force is applied the device could be damaged.In addition failure to complete the stroke may result in incomplete staple line.For additional information please refer to the instructions for use.A batch record review was performed and no anomalies were found during the manufacturing process.

Event Description

It was reported that during a cystectomy procedure, during first transection of bowel, the device worked well, but when returning the firing knob back into position in order to re-open the device, a "plastic sound" was heard by the staff.The reload was changed and when the physician started to push the knob in order to staple again, the firing knob broke after approximately 1cm.The physician believes that a grey plastic part from the device broke and might have fallen into the patient.That piece was not found.Procedure completed with same/like device.

Manufacturer Narrative

(b)(4) batch # m54295.Additional information received: what is the current status of the patient? stable, discharged.What were the indications for surgery? bladder cancer.What part of bowel was being transected? ilium.Please explain what is meant by there was a plastic sound? after first firing of the device, when placing the firing knob back to its position at the back, the surgeon experience difficulty pushing it back.When doing so, he heard a plastic sound.How does the surgeon fire the device (thumb, fingers, palm, etc)? fingers on firing knob.The analysis results found that the ntlc75 device was received with the firing mechanism damaged as the firing knob was detached and the slip block assembly was noted to be damaged.The device was received with a reload loaded in the device.The reload was received with the knife not completely within doghouse, fully fired and the swing tab in the unlocked position.This condition is consistent with an improper loading technique.When loading the cartridge in the device, make sure the cartridge is inside the channel track and the proper loading technique is being used.Please refer instructions for use.Due to the condition of the device, no functional test could be performed.The damage to the firing knob and slip block assembly is consistent with high (outside indicated use) staple forming forces; however, there is insufficient evidence to determine the cause of the higher loads.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.A batch record review was performed and the batch had no anomalies noted during the manufacturing process.

Manufacturer Narrative

(b)(4).Batch # m54295.Additional question and answer: are all of the pieces accounted for on the damaged component or is there a possibility that there may still be a small piece left behind in the patient? based on the damage of the slip block assembly, it is possible that a small piece may have been left behind.

• Brand Name: LINEAR CUTTERS - NTLC
• 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: 5163720
• MDR Text Key: 28819158
• Report Number: 3005075853-2015-06701
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K092577
• 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,Followup
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2020
• Device Catalogue Number: NTLC75
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/30/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2015
• 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