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

Model Number C0R50

Device Problems Material Puncture/Hole (1504); Gas/Air Leak (2946)

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

Event Date 10/23/2018

Event Type  malfunction  

Event Description

Air seal leak detected.Hole found in balloon.

• 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: 8288266
• MDR Text Key: 134457560
• Report Number: 8288266
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2019,12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0R50
• Device Catalogue Number: COR50
• Device Lot Number: 1320368
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA