MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII SHIELDED BLADED ACCESS SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFB33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2025
Type of Reportable Event	Malfunction
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: total laparoscopic hysterectomy.Event description: (name redacted) was the operating surgeon, performing a total laparoscopic hysterectomy.(name redacted) reported that is was a complex case with a number of adhesions.The trocar was positioned in the supra pubic region.(name redacted) used a laparoscopic retrieval bag to remove the ovaries.(name redacted) removed the trocar to extract the ovaries, and then replaced the trocar in the same incision to continue the procedure.A colorectal consultant supported the case, due to bowel adhesions.I have asked for the name of the colorectal surgeon and will report back.Towards the end of the case, (name redacted) was making a final observation of the abdominal area with the scope, before finishing the procedure.It was at this point that (name redacted) noticed the damage to the end of the cannula.(name redacted) spent approximately one hour to locate the missing pieces, and these were found in the drapes and on the floor.(name redacted) reported that no pieces were left in the patient's abdomen.Additional information received from applied medical representative via email on 04july25: retrieval bag used: [competitor device].Energy device used: [competitor device].Other instruments used: [competitor device] from our sets.Additional information received from applied medical representative via email on 07july25: patient is fine.Bladed trocars, inserted with minimal twist.Nothing noticeable with difficulty during insertion.No trocar used with a robot.We don¿t know when the cannula broke, so this is hard to know.We do know that the ¿shards¿ were found in the drapes and on the floor, and not in the patient.Intervention: (name redacted) spent approximately one hour to locate the missing pieces, and these were found in the drapes and on the floor.(name redacted) reported that no pieces were left in the patient's abdomen.Patient status: there was no direct impact the patient.Patient is fine.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.A historical trend analysis and review of production records was performed, and no relevant documentation was identified.
Event or Problem Description
Procedure performed: total laparascopic hysterectomy.Event description: (name redacted) was the operating surgeon, performing a total laparascopic hysterectomy.(name redacted) reported that is was a complex case with a number of adhesions.The trocar was positioned in the supra pubic region.(name redacted) used a laparascopic retrieval bag to remove the ovaries.(name redacted) removed the trocar to extract the ovaries, and then replaced the trocar in the same incision to continue the procedure.A colorectal consultant supported the case, due to bowel adhesions.I have asked for the name of the colorectal surgeon and will report back.Towards the end of the case, (name redacted) was making a final observation of the abdominal area with the scope, before finishing the procedure.It was at this point that (name redacted) noticed the damage to the end of the cannula.(name redacted) spent approximately one hour to locate the missing pieces, and these were found in the drapes and on the floor.(name redacted) reported that no pieces were left in the patient's abdomen.Additional information received from applied medical representative via email on 04july25: retrieval bag used: [competitor device].Energy device used: [competitor device].Other instruments used: [competitor device] from our sets.Additional information received from applied medical representative via email on 07july25: patient is fine.Bladed trocars, inserted with minimal twist.Nothing noticeable with difficulty during insertion.No trocar used with a robot.We don¿t know when the cannula broke, so this is hard to know.We do know that the ¿shards¿ were found in the drapes and on the floor, and not in the patient.Nca submitted an incident report on 15jul25: duplicate search was performed and it was identified to be this complaint.Discrepancy on event date was clarified with tm to be 28jun25.No new information was received.Intervention: (name redacted) spent approximately one hour to locate the missing pieces, and these were found in the drapes and on the floor.(name redacted) reported that no pieces were left in the patient's abdomen.Patient status: there was no direct impact the patient.Patient is fine.

• Brand Name: KII SHIELDED BLADED ACCESS SYSTEM
• 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: 22569570
• Report Number: 2027111-2025-00655
• Device Sequence Number: 3915787
• Product Code: GCJ
• UDI-Device Identifier: 00607915119843
• UDI-Public: (01)00607915119843
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: CFB33
• Device Catalogue Number: 101477621
• Device Lot Number: 1547049
• Was Device Available for Evaluation?: No
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown