MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS02, 5X100 KII SLEEVE ZTHR 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTS02
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: "laparoscopic cholecystectomy with firefly and intraoperative cholangiogram." event description: per medwatch # (b)(4), received via mail on 21sep2021: "a laparoscopic procedure was being performed utilizing the kii sleeve.The plastic sleeve melted in two pieces inside the patients body.All pieces of the sleeve were retrieved and accounted for.The melted trocar pieces were returned to the manufacturer for failure analysis.It is suspected that the instrument being used to remove several adhesions was being used for an excessive period of time due to the number of legions present.This could have contributed to the trocar melting.No harm came to the patient or healthcare providers." additional information received from user facility via email on 22sep2021: the concomitant device, suspected to be used for an excessive period of time to remove several adhesions with the kii sleeve, was not able to be specified and staff were unable to provide that information after multiple attempts.The materials management team stated that the device was returned, however no tracking information was saved.No additional pictures of the device could be provided since the device was returned prior to their knowledge of the event.Intervention: "all pieces of the sleeve were retrieved and accounted for." patient status: "no harm came to the patient".
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.This report is to follow up on medwatch # (b)(4).
Event or Problem Description
Procedure performed: "laparoscopic cholecystectomy with firefly and intraoperative cholangiogram" event description: per medwatch #(b)(4), received via mail on 21sep2021: "a laparoscopic procedure was being performed utilizing the kii sleeve.The plastic sleeve melted in two pieces inside the patients body.All pieces of the sleeve were retrieved and accounted for.The melted trocar pieces were returned to the manufacturer for failure analysis.It is suspected that the instrument being used to remove several adhesions was being used for an excessive period of time due to the number of legions present.This could have contributed to the trocar melting.No harm came to the patient or healthcare providers." additional information received from user facility via email on 22sep2021: the concomitant device, suspected to be used for an excessive period of time to remove several adhesions with the kii sleeve, was not able to be specified and staff were unable to provide that information after multiple attempts.The materials management team stated that the device was returned, however no tracking information was saved.No additional pictures of the device could be provided since the device was returned prior to their knowledge of the event.Intervention: "all pieces of the sleeve were retrieved and accounted for." patient status: "no harm came to the patient".
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.Based on the description of the event, it is likely that the reported event was caused by a heat producing instrument that came in contact with the inner cannula walls, resulting in fracturing of the cannula.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: CTS02, 5X100 KII SLEEVE ZTHR 12/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 12530212
• Report Number: 2027111-2021-00645
• Device Sequence Number: 17423821
• Product Code: GCJ
• UDI-Device Identifier: 00607915123499
• UDI-Public: (01)00607915123499(17)240601(30)01(10)1418119
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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: 06/01/2024
• Device Model Number: CTS02
• Device Catalogue Number: 101208701
• Device Lot Number: 1418119
• Was Device Available for Evaluation?: No
• 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: 09/21/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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 Age: 77 YR
• Patient Sex: Female
• Patient Weight: 82 KG