MAUDE Adverse Event Report: COVIDIEN ENDOCATCH GOLD* 10MM SPECIMEN POUCH; SINGLE USE SPECIMEN RETRIEVAL PRODUCT

Model Number ECATCH10G

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2015

Event Type  malfunction  

Event Description

Procedure: tubal ligation according to the reporter: the bag lining which is secured to the ring separated from the ring at the distal tip and was found in the trocar wound site of the patient's abdominal wall.All pieces were removed.Patient is currently stable.No blood loss.No extended or time.

Manufacturer Narrative

(b)(4).

• Type of Device: SINGLE USE SPECIMEN RETRIEVAL PRODUCT
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4791675
• MDR Text Key: 5804987
• Report Number: 9612501-2015-00260
• Device Sequence Number: 1
• Product Code: GCI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• 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

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ECATCH10G
• Device Catalogue Number: ECATCH10G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1