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

Model Number C0R50

Device Problems Break (1069); Dull, Blunt (2407)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/31/2017

Event Type  malfunction  

Event Description

During a robotic assisted procedure, the physician observed that there were broken pieces of the kii balloon blunt tip system's inner black cannula that had fallen into the abdomen.The physician was able to remove all of the pieces.The broken product was saved.

• 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: 7137697
• MDR Text Key: 95480506
• Report Number: 7137697
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2017,12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/03/2020
• Device Model Number: C0R50
• Device Lot Number: 1302171
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 103