MAUDE Adverse Event Report: COVIDIEN 10 MM ENDOCATCH BAG; CONTAINER, SPECIMEN MAILER AND STORAGE, TEMPERATURE CONTROLLED, STERILE

Model Number 6252103076

Device Problem Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 10/04/2021

Event Type  malfunction  

Event Description

Endo-catch bag did not deploy properly during laparoscopic procedure, knot within bag.Physician able to extract bag intact with specimen.Fda safety report id# (b)(4).

• Brand Name: 10 MM ENDOCATCH BAG
• Type of Device: CONTAINER, SPECIMEN MAILER AND STORAGE, TEMPERATURE CONTROLLED, STERILE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 12660129
• MDR Text Key: 277443480
• Report Number: MW5104722
• Device Sequence Number: 1
• Product Code: NNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6252103076
• Device Lot Number: FEP93611B
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17 YR