MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFS02, 5X100 KII SLEEVE ADVFIX 12/BX; LAPAROSCOPIC, GENERAL & PLASTIC SURGERY

Model Number	CFS02
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.This report is to follow-up medwatch #mw 5201030000-2019-8059.
Event or Problem Description
Medwatch # mw 5201030000-2019-8059.Date of event: (b)(4) 2018.Procedure performed: unknown.Event description: protective cap placed over balloon; unable to be used without rupturing balloon.Patient status: unknown.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.This event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow up medwatch report # (b)(4).
Event or Problem Description
Medwatch # mw (b)(4).Date of event: (b)(6) 2018.Procedure performed: unknown.Event description: protective cap placed over balloon; unable to be used without rupturing balloon.Patient status: unknown.

• Brand Name: CFS02, 5X100 KII SLEEVE ADVFIX 12/BX
• Common Device Name: LAPAROSCOPIC, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9287945
• Report Number: 2027111-2019-00626
• Device Sequence Number: 1934562
• Product Code: GCJ
• UDI-Device Identifier: 00607915117733
• UDI-Public: (01)00607915117733(17)201206(30)01(10)1311980
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

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: 12/06/2020
• Device Model Number: CFS02
• Device Catalogue Number: 101215501
• Device Lot Number: 1311980
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 11/21/2019
• Patient Sequence Number: 1