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

Model Number	C0R85
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2016
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 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
Lap.Chole.- "at the end of procedure, surgeon, to take off a gauze used during procedure, caught it with johann grasper and took it off through our c0r85 trocar.After trocar extraction he realized that part of tip trocar (fragment of about 5mm) was broken.He could not find anymore plastic piece and he doesn't know if it remained in patient abdomen.Event was reported to italian ministry of health as "incident." event sample is available but we need to wait legal time before organize its pick up (and if ministry decide not to check it by himself)." patient status - unknown.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering confirmed the tip of the cannula was fractured.Dimensional measurements of the device were performed and found to be within current manufacturing specifications.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.The root cause of the experience could not be determined.Applied medical continuously seeks to improve the form, function, and ease of use of its products.As part of this continuous process, applied medical is currently researching possible device enhancements intended to further minimize the potential for this type of incident to occur.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: 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: 5665537
• Report Number: 2027111-2016-00364
• Device Sequence Number: 49983
• Product Code: GCJ
• UDI-Device Identifier: 00607915118549
• UDI-Public: (01)00607915118549(17)171001(30)01(10)1255966
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K060096
• 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): 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2016
• Supplement Report FDA Received Date: 08/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other