MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION KII® BALLOON BLUNT TIP SYSTEM; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number C0R47

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/28/2018

Event Type  malfunction  

Event Description

Device failed to maintain insufflation to meet surgeon's needs.

• Brand Name: KII® BALLOON BLUNT TIP SYSTEM
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7450634
• MDR Text Key: 106193606
• Report Number: 7450634
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915116453
• UDI-Public: (01)00607915116453
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/14/2020
• Device Model Number: C0R47
• Device Catalogue Number: C0R47
• Device Lot Number: 1310210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 84