MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF03, 5X100 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic hiatal hernia.Event description: rep.Wasn't present for the case.Limited information was available at the time of reporting.The rep.Received an e-mail from his hospital contact that stated the following: "the trocar broke into many pieces inside the patient yesterday afternoon." the procedure being performed and patient status is currently unknown at this time.The product is available for return.Additional information received from applied medical account manager, via e-mail on september 9th, 2019: "procedure: laparoscopic hiatal hernia.Physician: dr.[name].Incident description: the obturator on the 5 x 100 mm trocar broke while in patient.All pieces were confidently recovered.The patient was not harmed.The broke trocar was disposed of and is not available to send back to applied medical." patient status: "the patient was not harmed.".
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.However, based on the description of the event and previous events that were reported to applied, it is likely that the fractured obturator was caused by a material abnormality, which occurred during the manufacturing process.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: laparoscopic hiatal hernia event description: rep.Wasn't present for the case.Limited information was available at the time of reporting.The rep.Received an e-mail from his hospital contact that stated the following: "the trocar broke into many pieces inside the patient yesterday afternoon." the procedure being performed and patient status is currently unknown at this time.The product is available for return.Additional information received from applied medical account manager, via e-mail on (b)(6) 2019: "procedure - laparoscopic hiatal hernia physician - dr.[name] incident description - the obturator on the 5 x 100mm trocar broke while in patient.All pieces were confidently recovered.The patient was not harmed.The broke trocar was disposed of and is not available to send back to applied medical." additional information received from applied medical account manager, via e-mail on (b)(6) 2019: "i have attached the pictures that the or materials manager sent me a day after the incident.Unfortunately, the pictures do not have a picture of the trocar itself and they have disposed of the broken trocar.I was able to follow up with the nurse in the case and she doesn't believe that another device was being used alongside the trocar." patient status: "the patient was not harmed.".

• Brand Name: CFF03, 5X100 KII FIOS ADVFIX 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9037148
• Report Number: 2027111-2019-00586
• Device Sequence Number: 2420279
• Product Code: GCJ
• UDI-Device Identifier: 00607915117641
• UDI-Public: (01)00607915117641(17)220527(30)01(10)1357337
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K083638
• 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: Initial,Followup
• Report Date (Section B): 10/23/2019

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: Health Professional
• Device Expiration Date: 05/27/2022
• Device Model Number: CFF03
• Device Catalogue Number: 101221001
• Device Lot Number: 1357337
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 10/23/2019
• Patient Sequence Number: 1