MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFB33, 11X100 KII SH BLD ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFB33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: colectomy.Event description: use of a single-use laparoscopic trocar during a colectomy.At the introduction, the end of the sleeve was broken on 2 cm broken element detached in the wall.Found in direct sight.Current state of the patient: none because piece recovered.Actions undertaken in the care establishment for patient care: use of another trocar type of intervention: use of another trocar.Patient status: no patient injury or illness occurred associated with the complaint event.
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 of a damaged cannula could not be confirmed.In the absence of the event unit, it is difficult to determine if the damaged cannula was caused by a device or manufacturing non-conformance.Applied medical has reviewed the details surrounding the event and related product and is unable to determine the root cause at this time.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: colectomy event description: use of a single-use laparoscopic trocar during a colectomy.At the introduction, the end of the sleeve was broken on 2 cm broken element detached in the wall.Found in direct sight.Current state of the patient: none because piece recovered.Actions undertaken in the care establishment for patient care: use of another trocar additional information received by email from applied medical representative on (b)(6)2020: this port was used as auxiliary port.Insertion method was introduction trocar under visual control.Type of intervention: use of another trocar patient status: no patient injury or illness occurred associated with the complaint event.

• Brand Name: CFB33, 11X100 KII SH BLD 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: 10168705
• Report Number: 2027111-2020-00481
• Device Sequence Number: 3361619
• Product Code: GCJ
• UDI-Device Identifier: 00607915119843
• UDI-Public: (01)00607915119843(17)221215(30)01(10)1377209
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/28/2020

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: 12/15/2022
• Device Model Number: CFB33
• Device Catalogue Number: 101246001
• Device Lot Number: 1377209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/28/2020
• Patient Sequence Number: 1