MAUDE Adverse Event Report: COVIDIEN VISIPORT PLUS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 5MM-11MM VERSASEAL PLUS SEAL

Device Problem Break (1069)

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

Event Date 09/07/2016

Event Type  malfunction  

Event Description

During a laparoscopic hiatal hernia repair, dr was using visiport plus optical obturator device 5mm-11mm during initial insufflation and the insufflator dial cap broke off after inserting visiport.

• Brand Name: VISIPORT PLUS
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 60 middletown avenue; north haven CT 06473
• MDR Report Key: 5982875
• MDR Text Key: 55792760
• Report Number: 5982875
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/01/2021
• Device Model Number: 5MM-11MM VERSASEAL PLUS SEAL
• Device Catalogue Number: 176773P
• Device Lot Number: J6A1201X
• Other Device ID Number: (01)10884521080775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 96