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

Catalog Number CDH25A

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation: 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.Further analysis of the device showed that the anvil did not removed easily from the device.Once the anvil was removed, the trocar was noted to be damaged.No functional test was performed due the condition of the device.No conclusion could be reached as to how the trocar became damaged.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during an unknown procedure, could not detach the anvil.During the surgery, opened the packing, could not detach the anvil from the device.Another device was used to complete the surgery.After surgery, our customer tried again, with big force, detached the anvil successfully.There were no adverse consequences to the patient.

• Brand Name: ILS 25MM, CURVED
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8046098
• MDR Text Key: 126515980
• Report Number: 3005075853-2018-14224
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2018

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: 04/30/2023
• Device Catalogue Number: CDH25A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1