MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. E-Z CLEAN; MEGADYNE LAPAROSCOPC HOOK INSULFFLATION

Lot Number	180482
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Plastic pieces flaked off tip of megadyne laparoscopic hook insufflation equipment.

• Brand Name: E-Z CLEAN
• Common Device Name: MEGADYNE LAPAROSCOPC HOOK INSULFFLATION
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; draper UT 84020
• MDR Report Key: 7330438
• Report Number: MW5075801
• Device Sequence Number: 307698
• Product Code: GEI
• UDI-Device Identifier: 10614559100660
• UDI-Public: 10614559100660
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Lot Number: 180482
• Other Device ID Number: 0100
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2018
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 109