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

Lot Number 1290316

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2017

Event Type  malfunction  

Event Description

During procedure, instrument tip broke off - not retained, physician able to retrieve.No harm to pt.Procedure: robotic-assist laparoscopic left inguinal hernia repair with mesh, umbilical hernia.

• Brand Name: KII BALLOON BLUNT TIP SYSTEM
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL; rancho santo margarita CA 92688
• MDR Report Key: 6785022
• MDR Text Key: 82567079
• Report Number: MW5071472
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1290316
• Was Device Available for Evaluation?: Yes
• 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: 61 YR