MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 45MM ARTICNG LNR CUTR LONG; STAPLE, IMPLANTABLE

Catalog Number LONG45A

Device Problems Product Quality Problem (1506); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # k5dn9z.Month and day unknown.Only year (2018) is known.Device evaluation: the analysis results found that the long45a device was received with the handles opened.The device was returned with a tr45w reload loaded in the device.The returned reload was returned fully fired.The firing mechanism was noted to be damaged.No functional test was performed due the condition of the device.While no conclusion could be reach on what cause the firing mechanism to fail, it is possible that the device was attempted to fire on thicker tissue than indicated causing an increase of the internal forces resulting in the component yielding.It should be noted 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 history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.The following information was requested, but unavailable: can you please clarify what issue occurred with the device? in what type of procedure was the device used? what was the product code of the cartridge reload? on which firing did this event occur (1st, 2nd, 12th, etc.)? did the device deliver any staples? if yes, were the staples formed properly? if yes, was the staple line complete? did the device cut? if yes, was the cut line complete? if yes, was there any issue with the cut line such as jagged, dull knife, irregular, etc? was there any difficulty opening the device? if yes, how was the device removed from the patient? if yes, did the jaws eventually open?.

Event Description

It was reported that product was received at (b)(6) complaint handling unit.Shipping doc: long45a; please return defective product; poor quality.No other details provided.

• Brand Name: 45MM ARTICNG LNR CUTR LONG
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7648052
• MDR Text Key: 112846512
• Report Number: 3005075853-2018-11020
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20705036002427
• UDI-Public: 20705036002427
• Combination Product (y/n): N
• PMA/PMN Number: K020779
• 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: 04/27/2018

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: 09/23/2018
• Device Catalogue Number: LONG45A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2013
• 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