MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 29MM, CURVED; STAPLE, IMPLANTABLE

Catalog Number CDH29A

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p58t3t.Device evaluation: the analysis results found that the cdh29a device arrived with the knife damaged and the anvil missing.The breakaway washer was not present and there were no staples present.The damaged of the knife is consistent when the device is fired over an already existing staple line, hard object or thicker tissue than indicated.No functional test was performed due the condition of the device.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.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 how the device was "defective"? where within the gap setting scale was the orange indicator prior to firing? what confirmation was received that the device was fully fired? did the device staple? was the staple line complete? were there any staples missing from the staple line? what was the shape of the staples (b-formation, irregular, legs straight)? were the staples deployed into the tissue? were the staples seen in the surgical field? did the device cut? was the cut line fully circumferential around the target tissue? if the device fully cut, were both tissue donuts present? if the device fully cut, were both donuts complete? how many counter-clockwise revolutions were used to open the device? how was it confirmed that the anvil was free from the tissue prior to removing? after firing was the adjusting knob turned ½ to ¾ revolutions? was the device rotated 90 degrees in both directions to ensure the anvil was free from the tissue?.

Event Description

It was reported that during a hemicolectomy procedure, the stapler was defective.Another device was used.No patient consequences reported.

• Brand Name: ILS 29MM, CURVED
• 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: 7469801
• MDR Text Key: 106883163
• Report Number: 3005075853-2018-09382
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20705036003462
• UDI-Public: 20705036003462
• Combination Product (y/n): N
• PMA/PMN Number: K983536
• 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: 03/14/2018

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: 10/21/2022
• Device Catalogue Number: CDH29A
• Device Lot Number: P4TC43
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2017
• 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