MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFB12, 5X100 KII SH BLD ADVFIX DP 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFB12
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic salpingo oophrectomy.Event description: laparoscopic procedure underway - all ports insitu mr [name redacted] drained a cyst with a laparoscopic needle via a port - the needle was then removed.The laparoscopic suction was then inserted, inside the cavity the seal was identified next to the suction tip.The plastic seal was retrieved from inside the abdomen with the laparoscopic graspers.Plastic seal stored in pot.Opened an unused port to confirm item removed from patients abdomen was also a seal.On the seal 9 small plastic ¿flaps¿ should be present - however is was found that one had broken off.Reported to mhra (b)(6) 2023 yellow card report id: 2023/006/013/501/005.Type of intervention: opened an unused port to confirm item removed from patients abdomen was also a seal.Patient status: no patient injury has been reported.
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: laparoscopic salpingo oophrectomy.Event description: laparoscopic procedure underway - all ports insitu mr [name redacted] drained a cyst with a laparoscopic needle via a port - the needle was then removed.The laparoscopic suction was then inserted, inside the cavity the seal was identified next to the suction tip.The plastic seal was retrieved from inside the abdomen with the laparoscopic graspers.Plastic seal stored in pot.Opened an unused port to confirm item removed from patients abdomen was also a seal.On the seal 9 small plastic "flaps" should be present - however is was found that one had broken off.Reported to mhra (b)(6) 2023 yellow card report id: 2023/006/013/501/005.Additional information received by customer via email on (b)(6) 2023: item was faulty the surgeon would not use as there were not safe faulty items found inside of them i am not 100 per cent sure.Type of intervention: opened an unused port to confirm item removed from patients abdomen was also a seal.Patient status: no patient injury has been reported.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation along with a clear component.Visual inspection confirmed the complainant¿s experience of a dislodged shield, as the returned component was identified to be the shield, an internal plastic component of the seal.The shield was missing a shield petal.Based on the description of the event and condition of the returned unit, it is likely that the dislodged shield was caused by non-axial insertion 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.".

• Brand Name: CFB12, 5X100 KII SH BLD ADVFIX DP 10/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17192706
• Report Number: 2027111-2023-00504
• Device Sequence Number: 5642292
• Product Code: GCJ
• UDI-Device Identifier: 00607915124106
• UDI-Public: (01)00607915124106(17)260215(30)01(10)1481063
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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: 02/15/2026
• Device Model Number: CFB12
• Device Catalogue Number: 101473834
• Device Lot Number: 1481063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown