MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 25MM, CURVED; STAPLE, IMPLANTABLE

Catalog Number CDH25A

Device Problems Separation Failure (2547); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.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.

Event Description

It was reported that during a laparoscopic low anterior resection, the anvil could not be detached after opening the package in the cdh25a.It could be detached after trying to detach several times but the surgeon felt resistance in connection, so another cdh was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Batch # r59611.The analysis results found that the cdh25a device arrived with no apparent damage, with staples present and with the breakaway washer uncut, indicating that the device had not been fired.After further inspection was noted that the device trocar was damaged resulting in a tighter fit between the anvil and the trocar.The device was tested for functionality with the returned washer and 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.It is possible that the component was damaged from the supplier, it should be noted that a 100% inspections takes place during manufacturing to ensure the device meets the require specifications; in addition, a sample of the batch is inspected at fgqa.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 25MM, CURVED
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8014930
• MDR Text Key: 126538404
• Report Number: 3005075853-2018-14018
• 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: 10/09/2018

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: 06/09/2023
• Device Catalogue Number: CDH25A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 10/29/2018
• Supplement Dates Manufacturer Received: 11/07/2018
• Supplement Dates FDA Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1