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	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: unknown.Event description: during the operation, it was noticed that a part of the trocar was smelled, or scraped off.Particle was glued to the trocar.Part was found in the abdomen of the patient.Additional information received from regional sales manager via phone on 03-nov-2020: according to the customer, a plastic piece (not rubber) was either scraped off or broken off of the trocar and fell into the patient.The customer could not see where the part had come from, it did not seem to come from the outside of the trocar.The piece was collected and stuck to the packaging of the trocar.It will be returned alongside the trocar.Additional information received from regional sales manager via email on 03-nov-2020: the part are by the trocar.The user doesn't know what colour the detached part is.The trocar is returning.Intervention: retrieval of separated part.Patient status: no patient injury.
Event or Problem Description
Procedure performed: unknown.Event description: during the operation, it was noticed that a part of the trocar was smelled or scraped off.Particle was glued to the trocar.Part was found in the abdomen of the patient.Additional information received from regional sales manager via phone on 03-nov-2020: according to the customer, a plastic piece (not rubber) was either scraped off or broken off of the trocar and fell into the patient.The customer could not see where the part had come from, it did not seem to come from the outside of the trocar.The piece was collected and stuck to the packaging of the trocar.It will be returned alongside the trocar.Additional information received from regional sales manager via email on 03-nov-2020: the part are by the trocar.The user doesn't know what colour the detached part is.The trocar is returning.Intervention: retrieval of separated part.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed as the particulate was not returned with the event unit and the event unit met current specifications.There were no visible non-conformances.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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: 10813395
• Report Number: 2027111-2020-00606
• Device Sequence Number: 14327997
• Product Code: GCJ
• UDI-Device Identifier: 00607915117641
• UDI-Public: (01)00607915117641(17)230907(30)01(10)1392897
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/19/2021

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: 09/07/2023
• Device Model Number: CFF03
• Device Catalogue Number: 101473818
• Device Lot Number: 1392897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1