MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR72,12X150 KII OPT ZTHR HDL 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTR72
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
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: unknown.Event description: translation: for some time, difficulty introducing instruments into the device.Noted by several members of the operating team.Additional information received by phone from applied medical representative on 11mar22: name of procedure being performed: unknown.Patient status : no consequence on patient.Instrumentation that was being used at the time of the incident is unknown the event unit has not been kept for expertise, however a representative unit of the same lot will be returned.It is unknown what the user did after experiencing the incident.It is unknown how many times this has been observed.The user observed inconsistent resistance during instrument manipulation.Patient status: no consequence on patient.
Event or Problem Description
Procedure performed: sleeve gastrectomy.Event description: translation: for some time, difficulty introducing instruments into the device.Noted by several members of the operating team.Additional information received by phone from applied medical representative on 11mar22: name of procedure being performed: unknown patient status : no consequence on patient instrumentation that was being used at the time of the incident is unknown the event unit has not been kept for expertise, however a representative unit of the same lot will be returned.It is unknown what the user did after experiencing the incident it is unknown how many times this has been observed the user observed inconsistent resistance during instrument manipulation.Additional information will be obtained from the 24 march when the next visit is planned.Additional information received by phone from applied medical representative on 4apr22: procedure being performed: sleeve gastrectomy instrumentation being used at the time of the incident: optical diam 10mm after experiencing the incident the user changed the device it is unknown how many times this incident occur.After my visit of the surgeon, i was confirmed that the user was unable to insert the instrument through the device.Patient status: no consequence on patient.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a representative sterile unit was returned.Testing was performed on the sterile unit; however, the complainant¿s experience could not be replicated as the sterile unit did not experience drag force.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 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.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: CTR72,12X150 KII OPT ZTHR HDL 6/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 ; 9497135765
• MDR Report Key: 13864457
• Report Number: 2027111-2022-00494
• Device Sequence Number: 5345330
• Product Code: GCJ
• UDI-Device Identifier: 00607915125059
• UDI-Public: (01)00607915125059(17)240713(30)01(10)1415739
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2022

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: 07/13/2024
• Device Model Number: CTR72
• Device Catalogue Number: 101418101
• Device Lot Number: 1415739
• 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: 03/11/2022
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OPTICAL DIAM 10MM STORZ
• Patient Sex: Prefer Not To Disclose