MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF03, 5X100 KII FIOS ADVFIX 6/BX; GCJ

Model Number	CFF03
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	01/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic left ovarian cystectomy.Event description: after the surgeon inserted the biopsy needle they heard a leaking sound.Whilst looking for the source of the leak, they found a piece inside the peritoneum.Type of intervention: the surgeon was able to retrieve the plastic bit that came off.Patient status: no patient injury occurred.
Event or Problem Description
Procedure performed: laparoscopic left ovarian cystecyomy.Event description: after the surgeon inserted the biopsy needle they heard a leaking sound.Whilst looking for the source of the leak, they found a piece inside the peritoneum.Type of intervention: the surgeon was able to retrieve the plastic bit that came off.Patient status: no patient injury occurred.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of seal component separation.The shield, a clear plastic component of the seal and the septum, a rubber internal component of the seal, were damaged.Based on the condition of the returned unit and the description of the event, it is likely that the torn septum and dislodged shield were caused by non-axial insertion or removal of asymmetrical instrumentation through the trocar.The damaged septum likely led to the loss of pneumoperitoneum.Applied medical¿s instructions for use states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: CFF03, 5X100 KII FIOS ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8341871
• Report Number: 2027111-2019-00348
• Device Sequence Number: 11251449
• Product Code: GCJ
• UDI-Device Identifier: 00607915117641
• UDI-Public: (01)00607915117641(17)210822(30)01(10)1333992
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 04/09/2019

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: 08/22/2021
• Device Model Number: CFF03
• Device Catalogue Number: 101221001
• Device Lot Number: 1333992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOPSY NEEDLE