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

Catalog Number CDH29A

Device Problem Defective Component (2292)

Patient Problem Fluid Discharge (2686)

Event Date 07/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information was not provided by the initial contact.Information is unavailable; device was not returned for evaluation.The device was disposed of and will not be returned.

Event Description

It was reported that during a colon procedure, a posterior stapling defect occurred; a leakage of the staples line was observed.The surgeon made a new cut of the colon and the rectum to remove the staples.Another like device was used to complete the procedure.No patient consequences were reported.

Manufacturer Narrative

(b)(4).Batch # m53l62.Additional information received: a posterior stapling defect occurred, a leakage of the staples line was observed.The surgeon made a new cut of the colon and the rectum to remove the staples.Another like device was used to complete the procedure.No patient consequence.The analysis results found that the cdh29a device arrived with the anvil missing, otherwise in good visual condition.As the original anvil was not received, further investigation with the original anvil could not be performed.The breakaway washer was not present and there were no staples present.The device was reloaded with staples, a new washer was placed on the device and it was tested for functionality with a test anvil; 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.No incident related to the reported event was observed during the batch record review.

• Brand Name: ILS 29MM CURVED
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5024732
• MDR Text Key: 24694534
• Report Number: 3005075853-2015-05247
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 08/03/2015

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: 04/05/2020
• Device Catalogue Number: CDH29A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1