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

Catalog Number	LONG45A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7648052
• Report Number: 3005075853-2018-11020
• Device Sequence Number: 16502138
• Product Code: GDW
• UDI-Device Identifier: 20705036002427
• UDI-Public: 20705036002427
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1