MAUDE Adverse Event Report: COOPERSURGICAL, INC. PNEUMO-MATIC INSUFFLATION NEEDLE; PNEUMOPERITONEUM NEEDLE

Model Number 900-200

Device Problems Device Markings/Labelling Problem (2911); Pressure Problem (3012)

Patient Problem No Patient Involvement (2645)

Event Date 10/21/2020

Event Type  malfunction  

Event Description

A total of (3) insufflation needles did not pass a high pressure evaluation by the surgeon prior to their use.A total of (3) devices identified.Two with expiration date 4/17/2023, and one with an expiration date of 6/16/2023.Fda safety report id # (b)(4).

• Brand Name: PNEUMO-MATIC INSUFFLATION NEEDLE
• Type of Device: PNEUMOPERITONEUM NEEDLE
• Manufacturer (Section D): COOPERSURGICAL, INC.
• MDR Report Key: 10733247
• MDR Text Key: 213255308
• Report Number: MW5097438
• Device Sequence Number: 1
• Product Code: FHO
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/22/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2023
• Device Model Number: 900-200
• Device Catalogue Number: 900-200
• Device Lot Number: 277793
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR