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

Model Number 173050G

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Open or Close (2921)

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

Event Date 10/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: during a lap left salpingo oophorectomy, first bag broke off from metal ring prior to loading the specimen.The second bag would not cinch and then the string broke off and the metal ring broke.The third bag was used and it worked fine to remove the specimen.The specimen was larger than usual ovary.To correct the condition a new bag was used.Additional information has been requested but not yet received.

• 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 avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6130503
• MDR Text Key: 60992306
• Report Number: 9612501-2016-00980
• 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: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 173050G
• Device Catalogue Number: 173050G
• Device Lot Number: J6G2780MX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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