MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SURGINEEDLE; PNEUMOPERITONEUM NEEDLE

Model Number 172015

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic cholecystectomy, the valve of the device dislodged and fell inside the patient¿s cavity.It was located and removed and the case was completed.There was no patient injury.

• Brand Name: SURGINEEDLE
• Type of Device: PNEUMOPERITONEUM NEEDLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7620528
• MDR Text Key: 112163374
• Report Number: 1219930-2018-03239
• Device Sequence Number: 1
• Product Code: FHO
• UDI-Device Identifier: 10884521080805
• UDI-Public: 10884521080805
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K863330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 172015
• Device Catalogue Number: 172015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR