MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORP. INZII RETRIEVAL SYSTEM ENDOSCOPIC POUCH; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CD001

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2022

Event Type  malfunction  

Event Description

The endoscopic pouch was missing from the inzii retrieval system.Fda safety report id# (b)(4).

• Brand Name: INZII RETRIEVAL SYSTEM ENDOSCOPIC POUCH
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORP.; rancho santa margarita CA 92688
• MDR Report Key: 15412710
• MDR Text Key: 299867248
• Report Number: MW5111991
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 09/09/2022

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
• Device Operator: Health Professional
• Device Model Number: CD001
• Device Catalogue Number: CD001
• Device Lot Number: 1455007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White