MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR73, 12X100 KII OPT ADVFIX 6/BX; GCJ

Model Number	CFR73
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation.A follow-up report will be provided upon completion of the investigation.This report is to follow up medwatch report # mw5073032.
Event or Problem Description
Procedure performed: "ventral hernia repair." event description: received via maude database, report #mw5073032 on 10-nov-2017: "cannula cap popped off and fell on the floor." type of intervention: n/a.Patient status: "0 patients were involved in the event.".
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.Based on the description of the event, it is likely that the seal housing dislodgement was caused by a dimension that did not meet specifications.The probability and criticality of harm resulting from this failure mode have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical has implemented process enhancements intended to further minimize the potential for this type of incident to occur.This report is to follow up medwatch #mw5073032.This type of event is deemed not reportable as it is unlikely to cause or contribute to death or serious injury.

• Brand Name: CFR73, 12X100 KII OPT ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7098576
• Report Number: 2027111-2017-02140
• Device Sequence Number: 11231223
• Product Code: GCJ
• UDI-Device Identifier: 00607915119898
• UDI-Public: (01)00607915119898(17)200704(30)01(10)1300418
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 12/27/2017

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: Other
• Device Expiration Date: 07/04/2020
• Device Model Number: CFR73
• Device Catalogue Number: 101245601
• Device Lot Number: 1300418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 12/27/2017
• Patient Sequence Number: 1