MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFS02, 5X100 KII SLEEVE ADVFIX 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFS02
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	01/08/2021
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: laparoscopy.Event description: laparoscopic gynae procedure.1 x 12mm & 2 x 5mm ports were used.Approx an hour into the case a 5mm port wasn't maintaining a good seal.A first entry port was also used in the procedure.Surgeon spotted an opaque plastic cap sitting on the patients bowel before removing the ports.She was a large lady and it was lucky it was detected and removed at that point.Email with photo of the cap sent to applied medical additional information received via email from user facility on 10jan2021 - confirming the event and alert date were (b)(6).Additional information received via email from applied medical team member on jan 11, 2021: further to my conversation earlier, just to confirm i have visited the bays and taken the attached photos while [] (theatre manager) and [] colleagues dismantled the kii sleeve to ensure that only the instrument seal became loose during the procedure and not any part of the double duck bill.I also have taken video of the dismantling but these are too large to send via email.This has provided reassurance to all concerned that there is no risk of anything being left in the patient.Patient status: nil that we are aware of.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the event unit confirmed that the shield, an internal plastic component of the seal, had separated from the seal and was damaged.Engineering also observed that the septum, an internal rubber component of the seal, had been torn.Based on the condition of the returned unit and description of the event, it is likely that the reported event was caused by non-axial insertion or removal of an asymmetrical instrument through the trocar.Applied medical¿s instructions for use (ifu) 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.".
Event or Problem Description
Procedure performed: laparoscopy.Event description: laparoscopic gynae procedure.1 x 12mm & 2 x 5mm ports were used.Approx an hour into the case a 5mm port wasn't maintaining a good seal.A first entry port was also used in the procedure.Surgeon spotted an opaque plastic cap sitting on the patients bowel before removing the ports.She was a large lady and it was lucky it was detected and removed at that point.Email with photo of the cap sent to applied medical additional information received via email from user facility on 10jan2021 - confirming the event and alert date were (b)(6).Additional information received via email from applied medical team member on jan 11, 2021: further to my conversation earlier, just to confirm i have visited [user facility] and taken the attached photos while [] (theatre manager) and [] colleagues dismantled the kii sleeve to ensure that only the instrument seal became loose during the procedure and not any part of the double duck bill.I also have taken video of the dismantling but these are too large to send via email.This has provided reassurance to all concerned that there is no risk of anything being left in the patient.Patient status: nil that we are aware of.

• Brand Name: CFS02, 5X100 KII SLEEVE ADVFIX 12/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: 11175227
• Report Number: 2027111-2021-00307
• Device Sequence Number: 14447351
• Product Code: GCJ
• UDI-Device Identifier: 00607915117733
• UDI-Public: (01)00607915117733(17)230908(30)01(10)1395228
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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: 09/08/2023
• Device Model Number: CFS02
• Device Catalogue Number: 101215501
• Device Lot Number: 1395228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1