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

Catalog Number CDH29A

Device Problems Defective Component (2292); Failure to Form Staple (2579); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Can you please clarify how many minutes or hours the procedure was extended by? were there any patient consequences?.

Event Description

It was reported that during an unknown procedure, defective device; once armed, the clamp did not close completely, partial stapling of the anastomosis was noticed.The surgeon has recovered the issue with a changing the device and he has performed a manual suture to perform the anastomis.Loss of procedure time.

Manufacturer Narrative

(b)(4).Batch # r5854u.Device evaluation: the analysis results found that the cdh29a device arrived with no apparent damage.The breakaway washer uncut and indented and there were no staples present.The device was reloaded with staples and tested for functionality with a test washer; 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 were noted to have the proper b-formed shape.The condition of the washer indicates that the device had not been fired through a full firing stroke or possibly that the orange indicator was not fully into the safe green firing range.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.Please reference the instructions for use for additional information.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• 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: 7728353
• MDR Text Key: 115475080
• Report Number: 3005075853-2018-11646
• Device Sequence Number: 0
• Product Code: GDW
• PMA/PMN Number: K983536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: CDH29A
• Device Lot Number: R40D6K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1