MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN VERSAPORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	179101
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter during a laparoscopic adrenalectomy the seal of the device, was broken though it was less than an hour.A new device was used due to the concern of pneumoperitoneum gas leakage.The broken part came with the forceps when removing, so nothing fell into the patient's cavity.The procedure was completed with another device.There was no patient injury.

• Brand Name: VERSAPORT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8416759
• Report Number: 1219930-2019-01485
• Device Sequence Number: 19235383
• Product Code: GCJ
• UDI-Device Identifier: 20884521081359
• UDI-Public: 20884521081359
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 179101
• Device Catalogue Number: 179101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1