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

Catalog Number CDH29A

Device Problems Failure to Advance (2524); Failure to Form Staple (2579); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.

Event Description

It was reported that in the course of a anterior resection procedure using cdh29a, an error occurred in the process of firing.When surgeon pulled back the safety lock and fired the trigger, the blade did not proceed and staples also weren't fired.As an emergency measure, the surgeon detached it from the tissue.There were no reported adverse consequences for the patient so far.

Manufacturer Narrative

Product complaint # (b)(4).Batch # r5a14f.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Device evaluation summary: the analysis results found that the cdh29a device arrived with no apparent damage, with the breakaway washer uncut, without marks and there were no staples present.Device returned was confirmed to have an uncut washer.Device batch information was reviewed, and it was confirmed to be manufactured within bounding time period of the field action, however based on review of manufacturing records, it was not confirmed to exhibit behavior associated with the field action.The device was reloaded with staples and tested with the returned washer for functionality; the device formed all the staples, as well as completely cut the test media and the breakaway washer without incident.The staple line was complete and the staples meet the staple form release criteria.It should be noted that before firing the device the orange indicator should be fully within the green range of the gap setting scale.In addition, it should be noted that if the firing sequence is not complete (the firing handle reaches its stopping point, and the firing trigger is parallel to the instrument handle) staples could be partially deployed without cutting the washer.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: ILS 29MM, CURVED
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8805683
• MDR Text Key: 151584978
• Report Number: 3005075853-2019-20509
• 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: foreign,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2019

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: 08/14/2023
• Device Catalogue Number: CDH29A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Manufacturer Received: 06/23/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 10/10/2019; 11/08/2019
• Supplement Dates FDA Received: 11/08/2019; 11/11/2019
• Removal/Correction Number: Z-1269-2019
• Patient Sequence Number: 1