MAUDE Adverse Event Report: COVIDIEN LP PREMIUM PLUS CEEA; STAPLE, IMPLANTABLE

Model Number 111989

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212); Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/26/2016

Event Type  malfunction  

Event Description

During initial surgery approximately 6 months ago, the ceea stapler was used.As part of the procedure, it is necessary to remove the plastic trocar tip before inserting the anvil.With a closed laparoscopic procedure the trochar tip may not be taken out of the body until the connection between the anvil and the stapler is complete.If the anastomosis is difficult, the trochar tip may not be removed until the connection is determined to be laying appropriately, with correct placement, right angle, with the correct tension.Because of limited visibility of the surgical field, distraction and focused concentration on securing the anastomosis, the trocar tip was forgotten and left in the surgical field.Approximately two months ago, the patient underwent a ct abdomen/pelvis with contrast which revealed "intraperitoneal metallic tubular density in the lower pelvis which appears to contact a loop of small bowel measuring approximately 3.5 x 0.8 cm and may represent a radiopaque retained foreign body".The patient returned to surgery approximately three weeks after the ct for the ileostomy take down and the retained stapler trochar tip was retrieved.While this is not generally a problem for open procedures, when done laparoscopically, it is easy to leave the trocar tip behind.Ideally, the device could be redesigned to reduce the chances of this happening.

• Brand Name: PREMIUM PLUS CEEA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 60 middletown ave.; north haven CT 06473
• MDR Report Key: 6228265
• MDR Text Key: 64039897
• Report Number: 6228265
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 111989
• Device Catalogue Number: 111989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; SURGICAL ROBOT
• Patient Outcome(s): Other
• Patient Age: 39 YR