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

Model Number	CFS12
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic right colectomy.Event description: [translation] at the start of the procedure, the surgeon saw a piece of trocar in the patient's abdomen.The surgeon retrieved the piece with difficulty and almost performed an exploratory laparotomy.Customer also submitted a complaint email/form via the tm.[translation] the surgeon noted the presence of a foreign body in the abdomen.This foreign body turned out to be a piece of trocar that had become detached.The surgeon removed the foreign body, but he had difficulty because it had moved into the small intestine and almost had to perform an exploratory laparotomy to find the element.Intervention: the surgeon retrieved the piece with difficulty and almost performed an exploratory laparotomy.Patient status: ok.
Additional Manufacturer Narrative
The event unit 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 right colectomy.Event description: [translation] at the start of the procedure, the surgeon saw a piece of trocar in the patient's abdomen.The surgeon retrieved the piece with difficulty and almost performed an exploratory laparotomy.Customer also submitted a complaint email/form via the tm.[translation] the surgeon noted the presence of a foreign body in the abdomen.This foreign body turned out to be a piece of trocar that had become detached.The surgeon removed the foreign body, but he had difficulty because it had moved into the small intestine and almost had to perform an exploratory laparotomy to find the element.Intervention: the surgeon retrieved the piece with difficulty and almost performed an exploratory laparotomy.Patient status: ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a black fragment.Visual inspection confirmed the complainant¿s experience of seal fragmentation.The black fragment matched the missing portion of the duckbill, an internal rubber component of the seal.Based on the description of the event and condition of the returned unit, the duckbill fragmentation was most likely caused by an asymmetrical instrument that was inserted or removed through the trocar in non-axial manner.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 documentations were identified.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as duckbill fragmentation is unlikely to cause or contribute to death or serious injury.

• 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: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 22330413
• Report Number: 2027111-2025-00602
• Device Sequence Number: 21191346
• Product Code: GCJ
• UDI-Device Identifier: 00607915119850
• UDI-Public: (01)00607915119850
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: CFS12
• Device Catalogue Number: 101472329
• Device Lot Number: 1524047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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
• Patient Sex: Unknown