MAUDE Adverse Event Report: APPLIED MEDICAL DISTRIBUTION CENTER APPLIED MEDICAL KII OPTICAL ACCESS SYSTEM; LAPROSCOPE, GENERAL & PLASTIC SURGERY

Model Number REF COR37

Device Problems Break (1069); Component Missing (2306); Contamination /Decontamination Problem (2895)

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

Event Date 11/06/2018

Event Type  malfunction  

Event Description

Pt undergoing removal of lap band and port when scrub tech noticed black plastic and clear plastic from the inside of the trocar was damaged and missing.Dr.Verified no pieces left in pt.Surgeon: (b)(6).

• Brand Name: APPLIED MEDICAL KII OPTICAL ACCESS SYSTEM
• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL DISTRIBUTION CENTER; rancho santa margarita CA 92688
• MDR Report Key: 8428485
• MDR Text Key: 139184835
• Report Number: MW5084976
• 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: Other
• Type of Report: Initial
• Report Date: 03/14/2019

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 Expiration Date: 07/19/2021
• Device Model Number: REF COR37
• Device Lot Number: 1331891
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2019
• 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: 50 YR