MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF75, 12X75 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF75
Medical Device Problem Codes	Fracture (1260); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection noted a hole in the balloon, confirming the complainant¿s experience of the balloon not inflating.There were also scratches and fractures observed on the cannula tip.Based on the condition of the returned unit, it is likely the balloon damage was caused by an instrument or object that came into contact with the unit during the procedure.The instructions for use (ifu) states, "do not allow sharp instruments or objects to come into contact with balloon.Use caution around metal clamps, staple lines and during secondary port placement." balloon damage is considered not reportable as it is unlikely to cause or contribute to death or serious injury.However, the event was reported due to the damage that was observed on the cannula tip of the returned device.Based on the condition of the returned unit, it is likely that the cannula damage was caused by an instrument or object that came into contact with the cannula during the procedure.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: unknown.Event description: this is a complaint from the market.Administrative no.(b)(6).Please refer to the complaint sheet for investigation.Balloon would not inflate.Report from the sales rep: the balloon would not inflate when inserted into a narrow space.Initial investigation report by [distributor]: the event unit was returned to [distributor] and visually inspected.The proximal side of the balloon was found to be holed (pic.1).The distal side of the cannula was scratched (pic.2).The unit will be returned to amr for further evaluation.Admin#: (b)(6).The component list was provided and the package, cannula and obturator are available for return.Additional information received via email on 09may2019 from [distributor]: under the visual inspection, tissue attached to the septum, i didn't know firmly is there was damage to the check valve.Metal retractors maybe were used.This was not a robotic procedure.Patient status: no patient injury.

• Brand Name: CFF75, 12X75 KII FIOS ADVFIX 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8735548
• Report Number: 2027111-2019-00489
• Device Sequence Number: 19476046
• Product Code: GCJ
• UDI-Device Identifier: 00607915136659
• UDI-Public: (01)00607915136659(17)210410(30)01(10)1321229
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2021
• Device Model Number: CFF75
• Device Catalogue Number: 101471079
• Device Lot Number: 1321229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1