MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF33, 11X100 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CFF33

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a damaged obturator tip.The tip of the obturator was fractured; however, the fragment was not returned for evaluation.Based on the condition of the returned unit, it is likely that the obturator tip contained a material abnormality, which could have made it more susceptible to damage.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.A bent obturator tip is not considered to be reportable as it is unlikely to cause or contribute to death or serious injury.However, the event is reportable due to the fractured obturator tip that was observed during the evaluation of the returned unit.

Event Description

Procedure performed: unknown.Event description: event date is unknown.Limited information was available at the time of the event.The trocar packaging was opened and it was noted that the obturator was bent.Another cff33 was opened and used in the case.There was no patient contact.Photos are not available.The device is available to be returned.Intervention: opened a new trocar to use in the case.Patient status: this incident was not patient related.

• Brand Name: CFF33, 11X100 KII FIOS ADVFIX 6/BX
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 10535884
• MDR Text Key: 212739559
• Report Number: 2027111-2020-00559
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915119874
• UDI-Public: (01)00607915119874(17)221215(30)01(10)1376559
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2022
• Device Model Number: CFF33
• Device Catalogue Number: 101245701
• Device Lot Number: 1376559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1