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

Catalog Number ECS29A

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2015

Event Type  malfunction  

Event Description

It was reported that during a sigmoid colectomy procedure, the surgeon reported that the device as defective and would not discuss the case.Unknown how case was completed.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).Additional information received: the surgeon states he had to oversew because stapler did not fire a circular continuous staple.What confirmation was received that the device was fully fired? yes.Where within the gap setting scale was the orange indicator prior to firing? unknown.Did the device staple? yes.Was the staple line complete? unknown based on what surgeon told me.Were there any staples missing from the staple line? unknown.What was the shape of the staples (b-formation, irregular, legs straight)? did the device cut? yes.Was the cut line fully circumferential around the target tissue? no.If the device fully cut, were all tissue layers present in both donuts when inspected? no the analysis results found that the ecs29a 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: ENDO ILS, 29MM, CURVED
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 4856966
• MDR Text Key: 5849961
• Report Number: 3005075853-2015-03780
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2015

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: 01/24/2020
• Device Catalogue Number: ECS29A
• Device Lot Number: M90K45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2015
• 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