MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF71, 12X150 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF71
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
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 the investigation.
Event or Problem Description
Procedure performed: bariatric.Event description: at the end of the operation when removing the trocar, it was noticed that a piece of plastic was missing at the tip of the sleeve.This was found and recovered in the patient.Customer wants to return the whole box with the same lot in the box in the box system.Type of intervention: piece found and recovered in the patient.Patient status: no patient injury.
Event or Problem Description
Procedure performed: bariatric.Event description: at the end of the operation when removing the trocar, it was noticed that a piece of plastic was missing at the tip of the sleeve.This was found and recovered in the patient.Customer wants to return the whole box with the same lot in the box in the box system.From user report, received from bfarm by email on 10jul2020: [translation] upon removal of the trocar it was noticed, that a plastic part of approximately 1x1 cm had broken off of the end of the trocar underneath the cuff.The plastic piece was palpated by the surgeon in the surgical field and was removed.An approximately 1-2mm large piece is missing from the broken off part.Type of intervention: piece found and recovered in the patient.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a missing cannula tip.A fragment was returned for evaluation; however, engineering observed that a piece of the cannula was not returned.Based on the condition of the returned unit and the event description, it is likely that the cannula tip fracture was caused by the forces applied to the tip during insertion and/or during the procedure.It is also possible that the cannula 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.Section e1 - corrected country from denmark to germany.

• Brand Name: CFF71, 12X150 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: 10247232
• Report Number: 2027111-2020-00496
• Device Sequence Number: 594318
• Product Code: GCJ
• UDI-Device Identifier: 00607915123048
• UDI-Public: (01)00607915123048(17)220425(30)01(10)1355919
• 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): 08/27/2020

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: 04/25/2022
• Device Model Number: CFF71
• Device Catalogue Number: 101255901
• Device Lot Number: 1355919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1