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

Model Number CD001

Device Problem Difficult to Open or Close (2921)

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

Event Date 04/26/2019

Event Type  malfunction  

Event Description

While using the applied medical resources corp., inzii retrieval system according to the mfr's instructions.It was noted that the device was unable to cinch close the endoscopic pouch.The gallbladder was able to be removed with the open pouch.Fda safety report id# (b)(4).

• Brand Name: INZII RETRIEVAL SYSTEM ENDOSCOPIC POUCH
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORP. ; rancho santa margarita CA 92688
• MDR Report Key: 8569087
• MDR Text Key: 143804021
• Report Number: MW5086289
• 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: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Model Number: CD001
• Device Catalogue Number: CD001
• Device Lot Number: 1346511
• Was Device Available for Evaluation?: No
• 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: 67 YR