MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF01, 5X150 KII FIOS ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF01
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a bent trocar.Engineering measured the wall thickness near the bend location and it was found to be uneven.The obturator was also cracked and fractured.Based on the condition of the returned unit, it is likely that the bent trocar was caused by a combination of the uneven wall thickness of the cannula and a high force that was applied to the trocar during insertion.It is possible that the obturator cracked and fractured due to a material abnormality; however, the cracks and fractures could have been caused by prolonged lipid exposure while the unit was in transit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.A bent trocar is considered not reportable as it is unlikely to cause or contribute to death or serious injury.The event is being reported due to the fracture that was observed on the obturator during evaluation of the product.
Event or Problem Description
Procedure performed: unk.Event description: trocar was bent; was not used on patient.Patient status: ni.

• Brand Name: CTF01, 5X150 KII FIOS ZTHR 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: 8998300
• Report Number: 2027111-2019-00581
• Device Sequence Number: 3380087
• Product Code: GCJ
• UDI-Device Identifier: 00607915124014
• UDI-Public: (01)00607915124014(17)211213(30)01(10)1342846
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K041795
• 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
• Report Date (Section B): 09/11/2019

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: Other
• Device Expiration Date: 12/13/2021
• Device Model Number: CTF01
• Device Catalogue Number: 101412701
• Device Lot Number: 1342846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1