MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. LAPAROSCOPIC TUBING, 6.5MM, WITH LURE CONNECTOR; MEGADYNE¿ LAPAROSCOPIC TUBING

Model Number 2390J

Device Problems Misassembled (1398); Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No lot or batch number was provided therefore a device history could not be done.

Event Description

It was reported that during a laparoscopic hysterectomy, air leak occurred from between trocar and the tip of the evacuation tube.The issue occurred 1 hour after the operation was started.The device was used on the laparoscopic mode.The surgeon commented that the suction seems to be not stopped.The trocar was loose.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 2/28/2022.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the 2390j tuning was received with no apparent damage.The tubing was secured correctly to a test 2550j (lot #20024) filter to test the tubing and no leak was detected within tubing and connecting joints.Although no conclusion could be reach on the cause of the reported event.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.

• Brand Name: LAPAROSCOPIC TUBING, 6.5MM, WITH LURE CONNECTOR
• Type of Device: MEGADYNE¿ LAPAROSCOPIC TUBING
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• Manufacturer (Section G): MEGADYNE MEDICAL PRODUCTS, INC.
• Manufacturer Contact: kara ditty-bovard ; 11506 south state street; draper, UT 84020 ; 6107428552
• MDR Report Key: 12797612
• MDR Text Key: 284986962
• Report Number: 1721194-2021-00082
• Device Sequence Number: 1
• Product Code: FCZ
• UDI-Device Identifier: 10614559104590
• UDI-Public: 10614559104590
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2390J
• Device Catalogue Number: 2390J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1