MAUDE Adverse Event Report: COVIDIEN ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL; LARYNGOSCOPE, ENDOSCOPE

Model Number 173050G

Device Problems Hole In Material (1293); Material Perforation (2205)

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

Event Date 06/22/2015

Event Type  malfunction  

Event Description

Procedure: cholecystectomy.According to the reporter: the bag is perforated.Defect noted prior to use on patient.Nothing fell into the patient's cavity, defect noticed before use.

Manufacturer Narrative

(b)(4).

Event Description

Additional information provided: nothing fell into the patient's cavity, defect noticed before use.The bag didn't detach from the ring.They found it broken.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) conducted an evaluation two devices sealed.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, and an evaluation of the clinically applied device.Investigation team verified the received samples and confirmed that the sutures were properly inserted in the gold rings, the knots were made correctly and the sutures were cut at the right distance.Afterward, both devices were submitted to functional evaluations where no abnormality was detected.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.There were no adverse patient events reported as a result of the alleged event.Should new information become available, the file will be re-opened and reassessed at that time.

• Brand Name: ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL
• 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: 4892239
• MDR Text Key: 6018799
• Report Number: 9612501-2015-00383
• Device Sequence Number: 1
• Product Code: GCI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K922123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: 173050G
• Device Catalogue Number: 173050G
• Device Lot Number: J4L1381MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1