MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. UNK_SMOKE EVACUATION - ACE700; MEGADYNE ACE 700 ZIP PEN C CONNECTOR

Catalog Number UNK_SMOKE EVACUATION - ACE700

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unknown; captured as awareness date.This report is related to a clinical evaluation report from a related research activity database; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.

Event Description

It was reported that this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) for patients undergoing unknown procedure.The reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: patient had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, bleeding.Patient had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, blood transfusion.

• Brand Name: UNK_SMOKE EVACUATION - ACE700
• Type of Device: MEGADYNE ACE 700 ZIP PEN C CONNECTOR
• 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: 11769867
• MDR Text Key: 250814257
• Report Number: 1721194-2021-00038
• Device Sequence Number: 1
• Product Code: FYD
• Combination Product (y/n): N
• PMA/PMN Number: K141587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMOKE EVACUATION - ACE700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention