MAUDE Adverse Event Report: COOPER SURGICAL PNEUMO MATIC INSUFFLATION NEEDLE

Lot Number 213729

Device Problem Failure to Advance (2524)

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

Event Date 08/11/2017

Event Type  malfunction  

Event Description

Two (2) cooper surgical, pneumo-matic insufflation needles did not pass co2 pressure test with dr.(b)(6).

• Brand Name: PNEUMO MATIC INSUFFLATION NEEDLE
• Type of Device: INSUFFLATION NEEDLE
• Manufacturer (Section D): COOPER SURGICAL; trumbill CT 06611
• MDR Report Key: 6800875
• MDR Text Key: 83032117
• Report Number: MW5071641
• Device Sequence Number: 2
• Product Code: FHO
• Combination Product (y/n): N
• 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: 08/14/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 213729
• 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: 28 YR