MAUDE Adverse Event Report: APPLIED MEDICAL CFS22, 12X100 KII SLEEVE ADVFIX 12/BX; GCJ

Model Number	CFS22
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
Event or Problem Description
Da vinci radical prostatectomy - "trocar was inserted.After removal of the obturator, the cap with the seal separated off the cannula.In several trials, it was not possible to attach the cap to the cannula." patient status "ok.".
Additional Manufacturer Narrative
Additional information was requested and provided.Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering no visible damage to the unit and noted the seal sub-assembly was intact.Engineering attempted to separate the seal housing form the cannula and found the device functioned properly and met design specifications.The root cause of the incident could not be determined, as engineering was unable to replicate the incident.Although the exact root cause of the experience could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
Additional Manufacturer Narrative
Additional information was requested and provided.Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering found no visible damage to the unit and noted the seal sub-assembly was intact.Engineering attempted to separate the seal housing form the cannula and found the device functioned properly and met design specifications.The root cause of the incident could not be determined, as engineering was unable to replicate the incident.Although the exact root cause of the experience could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• Brand Name: CFS22, 12X100 KII SLEEVE ADVFIX 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5429206
• Report Number: 2027111-2016-00102
• Device Sequence Number: 10917303
• Product Code: GCJ
• UDI-Device Identifier: 00607915117740
• UDI-Public: (01)00607915117740(17)180517(30)01(10)1246350
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2016

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: 05/17/2018
• Device Model Number: CFS22
• Device Catalogue Number: 101245301
• Device Lot Number: 1246350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/10/2016
• Supplement Report FDA Received Date: 04/05/2016; 04/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1