MAUDE Adverse Event Report: COVIDIEN ENDO CATCH* II 15MM SPECIMEN POUCH; LARYNGOSCOPE, ENDOSCOPE

Model Number 173049

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one endo catch ii 15mm specimen pouch opened by the account.Upon visual examination, it was noted that the bag was partially disengaged from the metal ring.The green pull ring was received seated in the handle.The bag cinched and the ring deployed and retracted without difficulty.Visual and functional testing of the returned product confirmed the product, as received, did not meet release specifications due to the disengaged bag.Product analysis suggests the product was used in a surgical procedure.The reported condition suggests that the green ring and suture line were not pulled, thus indicating that the bag did not detach as a result of this action.Replication of these conditions may occur if instead, the plunger is retracted after bag deployment, causing bag detachment.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

Event Description

According to the reporter, during the operation, the surgeon pulled the green ring but the string was not pulled up therefore the pouch would not close.There was no patient injury.No further information is available.

• Type of Device: LARYNGOSCOPE, ENDOSCOPE
• 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: 6376059
• MDR Text Key: 69019096
• Report Number: 9612501-2017-00313
• Device Sequence Number: 1
• Product Code: GCI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 173049
• Device Catalogue Number: 173049
• Device Lot Number: J6F0075X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1