MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR73, 12X100 KII OPT ADVFIX 6/BX; GCJ

Model Number	CFR73
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has been returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: diagnostic laparoscopic surgery for endometriosis incident description: "received a phone call from health services manager at [hospital name] at 0900hrs this morning stating that one of our trocars had broken off during a procedure last night.The procedure was for a diagnostic lap case for endometriosis.Spoke to one of the nurses involved in the case and she stated that the trocar in question did not break during entry into the abdomen.The trocar broke on insertion of a 5mm lateral port.The nurse stated that the surgeon involved was showing an insertion technique to the registrar.The registrar inserted the 5mm lateral port and it connected with the 12mm port.The registrar tilted the 5mm port and that is when the 12mm trocar snapped.The snapped piece of plastic was not found and the patient has been informed." patient status: patient injury or illness did not occur associated with the complaint event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a fractured cannula tip.The fractured piece was not returned with the event unit.Based on the condition of the returned unit and the description of the event, it is likely that the tip fracture was caused by force applied at the cannula tip by the 5mm lateral port that made contact with the event unit during the procedure.The probability and criticality of harm resulting from this failure mode have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible device and/or process enhancements intended to further minimize the potential for this type of event to occur.

• Brand Name: CFR73, 12X100 KII OPT ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7531902
• Report Number: 2027111-2018-00183
• Device Sequence Number: 10793644
• Product Code: GCJ
• UDI-Device Identifier: 00607915119898
• UDI-Public: (01)00607915119898(17)200725(30)01(10)1302336
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 06/06/2018

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: 07/25/2020
• Device Model Number: CFR73
• Device Catalogue Number: 101245601
• Device Lot Number: 1302336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/06/2018
• 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: 5MM LATERAL PORT; 5MM LATERAL PORT