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	03/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the 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
Procedure "not mentioned" - "when the camera was taken out of the trocar, the seal came off the sleeve.This happened several times so the doctor lost pneumo every time." patient status - healthy.
Additional Manufacturer Narrative
Additional information was requested from the customer and provided.Investigation summary: the event unit was returned for evaluation.Upon inspection, no visible damage was noted.Engineering attempted to dislodge the seal from the cannula, but was unable to replicate the customer experience.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.It is possible that the latch tabs may have been unintentionally activated, which could cause the seal to separate from the cannula.Although the root cause of the incident 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: 5546165
• Report Number: 2027111-2016-00266
• Device Sequence Number: 146242
• Product Code: GCJ
• UDI-Device Identifier: 00607915117740
• UDI-Public: (01)00607915117740(17)160331(30)01(10)1192526
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 03/08/2016

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: 03/31/2016
• Device Model Number: CFS22
• Device Catalogue Number: 101256501
• Device Lot Number: 1192526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2016
• Supplement Report FDA Received Date: 06/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1