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

Model Number	CFR73
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of investigation.There is no report of serious injury or death associated with this event.
Event or Problem Description
Procedure performed unknown - "this is a complaint from the market.Administrative no.(b)(4).Please refer to the complaint sheet for investigation.Report from the sales rep: the septum was damaged and the rubber fragment was found outside of the patient cavity.The duration of the procedure was approx.7 to 8 hours.Ultrasonic energy device was inserted into the event trocar.Initial investigation report by (b)(6) olympus: the event unit was returned to olympus and visually inspected.The shield had no visible damage; the ddb had been cut by the customer.The reported damage to the septum was confirmed; the septum was missing a portion; after putting the returned fragment(approx.9 mm x 11 mm, onto the damaged septum location, two missing locations were confirmed.The sizes of two missing locations (a and b) were respectively approx.1.6mm×1.5mm and 1.4mm×2.2mm.The unit will be returned to (b)(6) for further evaluation.Admin#(b)(4)." patient status: no patient injury.
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation.Upon inspection, engineering noted fragmentation of an internal rubber component of the seal.The rubber fragments returned matched the missing portion on the seal.The likely root cause of the damage to the seal is an instrument.Applied medical's instructions for use states that "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• 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: 6412120
• Report Number: 2027111-2017-01602
• Device Sequence Number: 674948
• Product Code: GCJ
• UDI-Device Identifier: 00607915119898
• UDI-Public: (01)00607915119898(17)190201(30)01(10)1264230
• Combination Product (Y/N): N
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2017

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: 02/01/2019
• Device Model Number: CFR73
• Device Catalogue Number: 101256001
• Device Lot Number: 1264230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 05/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ULTRASONIC ENERGY DEVICE