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

Model Number CDH29A

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t4128e.Device analysis: the analysis results found that the cdh29a device arrived with no apparent damage.The breakaway washer was present and uncut, and the device was fully loaded with staples, indicating that the device had not being fired.Further analysis shows that when the adjusting knob was rotated to the open position, the handle shroud was opening from the knob area to the indicator label, which does not allow the device to extend the trocar.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformance were identified.No conclusion could be reached as to how the handle became open.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.

Event Description

It was reported that during a laparoscopic anterior resection, the grip of the device cracked when the adjusting knob was rotated to close before use.Cdh33a was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Brand Name: ILS 29MM, CURVED
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 9819300
• MDR Text Key: 200249691
• Report Number: 3005075853-2020-01534
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036003465
• UDI-Public: 10705036003465
• 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: 01/28/2020

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 Model Number: CDH29A
• Device Catalogue Number: CDH29A
• Device Lot Number: T4128E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1