MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII SLEEVE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFS02
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	05/15/2024
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: laparoscopic cholecystectomy.Event description: as the surgeon was putting the aspirator into the trocar, they were placing it into the trocar at an angle and had to push it down the trocar with some force.While pushing the aspirator down, the aspirator damaged the clear plastic piece of the seal and pushed it down the cannula and into the patient's abdomen.The surgeon pulled the piece out of the patient's abdomen.The piece was fully intact.There is a small split/hole where the aspirator poked and shoved it down, but the piece is still whole.It is confirmed that everything was retrieved from the patient's abdomen.The surgeon tried to replicate the event with a demo trocar and aspirator, and the event did recur however the surgeon had to use much more force during this demonstration in order to remove the clear plastic part from the seal.The product is available for return.Type of intervention: pulled the piece out of the patient's abdomen.Patient status: patient was okay.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: as the surgeon was putting the aspirator into the trocar, they were placing it into the trocar at an angle and had to push it down the trocar with some force.While pushing the aspirator down, the aspirator damaged the clear plastic piece of the seal and pushed it down the cannula and into the patient's abdomen.The surgeon pulled the piece out of the patient's abdomen.The piece was fully intact.There is a small split/hole where the aspirator poked and shoved it down, but the piece is still whole.It is confirmed that everything was retrieved from the patient's abdomen.The surgeon tried to replicate the event with a demo trocar and aspirator, and the event did recur however the surgeon had to use much more force during this demonstration in order to remove the clear plastic part from the seal.The product is available for return.Type of intervention: pulled the piece out of the patient's abdomen.Patient status: patient was okay.
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 shield dislodgment and a torn septum.The clear component was identified to be a shield, an internal plastic component of the seal.Based on the condition of the returned unit and description of the event, it is likely that the dislodged shield and fragmented septum were caused by the non-axial insertion or removal of asymmetrical instruments 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.¿ applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.[correction] sections d1 and d4 (primary unique device identification number and additional unique device identification number) have been updated.

• Brand Name: KII SLEEVE
• 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: 19376850
• Report Number: 2027111-2024-00660
• Device Sequence Number: 15340775
• Product Code: GCJ
• UDI-Device Identifier: 00607915117733
• UDI-Public: (01)00607915117733
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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 Model Number: CFS02
• Device Catalogue Number: 101215501
• Device Lot Number: 1511704
• 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: 05/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LAPAROSCOPIC SCISSORS, GRASPERS.; MONOPOLAR L HOOK, ASPIRATOR, RETRIEVAL BAG.
• Patient Sex: Unknown