MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF71, 12X150 KII FIOS ADVFIX 6/BX; GCJ

Model Number	CFF71
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2017
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.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.There is no report of serious injury or death associated with this event.
Event or Problem Description
Da vinci ventral hernia repair - the scrub tech noticed that the seal was leaking throughout the case and the instrument exchanges were rough.At the end of the procedure the doctor did a final inspection and noticed that part of the seal had fallen into the patient.It was a torn section of the black inner seal and the doctor was able to safely remove the section of the seal.This port was used for instruments and was used by both the health professional and the robot "piggy back port".The robot was a da vinci si robot multiple instruments were used, but the sales rep was only able to get confirmation about an l hook.Devinci si robot was used.Additional information received from sales representative on february 15, 2017: the sales rep spoke to the doctor about the "piggy back port".The doctor used out cff71 as an access port and would insert the da vinci 8mm trocar with no obturator inside the cff71.Type of intervention: seal was safely removed.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 fragment 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: CFF71, 12X150 KII FIOS ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6346908
• Report Number: 2027111-2017-01434
• Device Sequence Number: 16359052
• Product Code: GCJ
• UDI-Device Identifier: 00607915123048
• UDI-Public: (01)00607915123048(17)191006(30)01(10)1280186
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2017

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: 10/06/2019
• Device Model Number: CFF71
• Device Catalogue Number: 101255901
• Device Lot Number: 1280186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 05/03/2017
• 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: L HOOK