MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 33MM, CURVED; STAPLE, IMPLANTABLE

Catalog Number CDH33A

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Were there any patient consequences?.

Event Description

It was reported that during the rectosigmoidectomy surgery, the circular stapler nº 33, presented a defect.Stapler had normal appearance, but during activation, there were no closed staples, only the cut of the tissues with immediate opening of the colon, extravasation of enteric liquid and risk to the patient.According to the surgeon's report, the surgery was completed by suturing the patient with surgical thread instead of the stapler.There were no patient consequences reported.

Manufacturer Narrative

Product complaint # (b)(4).Batch # n53r3n.Device evaluation: the analysis results found that the cdh33a device arrived with no apparent damage.The breakaway washer was present and cut and there were no staples present, indicating that the device achieved a full firing stroke; however the knife was noted to have nicks.The device was reloaded with staples, a new washer was placed on the device and it was tested for functionality.It fired and 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 damaged on the knife is consistent when the device is fired over an already existing staple line, hard object or thicker tissue than indicated.The batch history record was reviewed and identified a defect/issue but was not related to the reported incident were found.In addition, no protocols or ncr related to the complaint, were found during the manufacturing process.

• Brand Name: ILS 33MM, CURVED
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7654577
• MDR Text Key: 113005259
• Report Number: 3005075853-2018-11079
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20705036003479
• UDI-Public: 20705036003479
• 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
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

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: 01/26/2021
• Device Catalogue Number: CDH33A
• Device Lot Number: N4L76Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 11/07/2018
• Supplement Dates FDA Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1