MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF73, 12X100 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF73
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2020
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 investigation.
Event or Problem Description
Procedure performed: colectomy.Event description: the trocar was inserted and after that the double duck bill was found in the abdomen.Unfortunately the nurse discarded the trocar, but the doctor made a pic.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation, however, a photo of a detached duckbill, an internal component of the seal, was provided by the complainant.Engineering determined that the geometrical structure of the duckbill did not match any components used to manufacture applied medical¿s products.Based on the photo provided by the complainant, the detached duckbill did not originate from an applied medical product.Therefore, applied medical is unable to confirm that a product malfunction occurred with an applied medical product and this incident is not reportable.
Event or Problem Description
Procedure performed: colectomy.Event description: the trocar was inserted and after that the double duck bill was found in the abdomen.Unfortunately the nurse discarded the trocar, but the doctor made a pic.Additional information from applied medical representative via email on 21sep2020: i received the answer from the hospital, that the complaint was unfortunately a mistake, cause our trocar was not affected.Patient status: no patient injury.

• Brand Name: CFF73, 12X100 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: 10417901
• Report Number: 2027111-2020-00529
• Device Sequence Number: 3105061
• Product Code: GCJ
• UDI-Device Identifier: 00607915117658
• UDI-Public: (01)00607915117658(17)221202(30)01(10)1376119
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 09/22/2020

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: 12/02/2022
• Device Model Number: CFF73
• Device Catalogue Number: 101245501
• Device Lot Number: 1376119
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 09/22/2020
• Patient Sequence Number: 1