MAUDE Adverse Event Report: COVIDIEN ENDO CATCH GOLD SPECIMEN RETRIEVAL POUCH; ENDO CATCH SPECIMEN RETRIEVAL POUCH

Model Number	173050G
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Plastic piece from endo catch bag was left behind in the pt after the bag was deployed and specimen was removed from the pt.The item was retrieved and no harm noted to the pt.The ring of the pouch is not intact after removing the item and examining the device.No harm to patient.

• Brand Name: ENDO CATCH GOLD SPECIMEN RETRIEVAL POUCH
• Common Device Name: ENDO CATCH SPECIMEN RETRIEVAL POUCH
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 5553750
• Report Number: MW5061512
• Device Sequence Number: 375111
• Product Code: GCI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 03/31/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2018
• Device Model Number: 173050G
• Device Lot Number: J5L2197MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 83