MAUDE Adverse Event Report: APPLIED MEDICAL C0R85, 12X100MM KII BLT TIP SYS 6/BX; GCJ

Model Number	C0R85
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided 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.(b)(4).
Event or Problem Description
Lap chole - "trocar went without any issue, then the top portion broke (outside the body) as the camera was being inserted.Dr (b)(6) performed this procedure." patient status - patient is fine.Medwatch report: lap cholecystectomy on (b)(6) 2016 - "trocar was inserted without difficulty.When the scope was placed into the trocar the top of the trocar fell apart.No harm to the patient, no fragments or foreign bodies needed to be retrieved from inside the patient.".
Additional Manufacturer Narrative
Additional information received.We have tried to obtain the incident device for evaluation with no success.The event unit was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.A review of the manufacturing records indicates this lot passed all manufacturing and quality inspections.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.Although the root cause could not be determined, applied medical continuously seeks to improve the form, function and ease of use of its products and will continue to monitor its vigilance system for trends and take appropriate actions as necessary.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.This report is to follow up with medwatch# (b)(4).
Event or Problem Description
Additional information received via email from customer on february 12, 2016: it was described as the "cuff" at the external opening where the camera is inserted which i would assume is what you are calling the stability cone.It broke into several pieces.Since no internal harm was noted i believe that the "seal" was intact.

• Brand Name: C0R85, 12X100MM KII BLT TIP SYS 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5405764
• Report Number: 2027111-2016-00094
• Device Sequence Number: 382981
• Product Code: GCJ
• UDI-Device Identifier: 00607915118549
• UDI-Public: (01)00607915118549(17)171001(30)01(10)1255966
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• 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: Followup
• Report Date (Section B): 12/06/2016

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: 10/01/2017
• Device Model Number: C0R85
• Device Catalogue Number: 100964801
• Device Lot Number: 1255966
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2016
• Supplement Report FDA Received Date: 12/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR