MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R85, 12X100MM KII BLT TIP SYS 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0R85
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lap hernia.Event description: "turtleneck" would not lock.Upon review, staff noticed that it was missing an "o" ring.Dr.[name] was the surgeon.Product available for return.Additional information received via email for medwatch #(b)(4) on (b)(6) 2022: hussan trocar in patient for procedure.Doctor sponge pulled out through hussan trocar.Trocar became dislodged.Trocar reintroduced into patient and locking mechanism would not lock.Trocar removed from field and inspected.Trocar found to be missing a plastic o ring from inside the turtleneck piece of trocar.Cavity searched by md.Or searched by staff.Missing piece not located.Additional information received via email from user facility on (b)(6) 2022: unable to answer accurately if the entire seal housing or cap detached.Unsure of what turtleneck is.This missing piece was an inner piece.No pictures of device are available.Patient status: discharged.
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.This report is to follow-up mw #(b)(4).
Event or Problem Description
Procedure performed: lap hernia.Event description: "turtleneck" would not lock.Upon review, staff noticed that it was missing an "o" ring.Dr.[name] was the surgeon.Product available for return.Additional information received via email for medwatch # (b)(4) on 23sep2022: hussan trocar in patient for procedure.Doctor sponge pulled out through hussan trocar.Trocar became dislodged.Trocar reintroduced into patient and locking mechanism would not lock.Trocar removed from field and inspected.Trocar found to be missing a plastic o ring from inside the turtleneck piece of trocar.Cavity searched by md.Operationg room searched by staff.Missing piece not located.Additional information received via email from user facility on 28sep2022: unable to answer accurately if the entire seal housing or cap detached.Unsure of what turtleneck is.This missing piece was an inner piece.No pictures of device are available.Patient status: discharged.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Functional testing confirmed the complainant¿s experience of trocar slippage as the cone assembly did not lock onto the cannula when the lever was actuated.Upon closer inspection, an insert was observed to be missing from the cone assembly.Based on the condition of the returned unit, it is likely that the reported event was caused by the missing insert that was not installed during the manufacturing process.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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 a non-functioning cone is unlikely to cause or contribute to death or serious injury.This report is to follow up medwatch #(b)(4).

• Brand Name: C0R85, 12X100MM KII BLT TIP SYS 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: 15538100
• Report Number: 2027111-2022-00758
• Device Sequence Number: 12533558
• Product Code: GCJ
• UDI-Device Identifier: 00607915118549
• UDI-Public: (01)00607915118549(17)250608(30)01(10)1455627
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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: 06/08/2025
• Device Model Number: C0R85
• Device Catalogue Number: 100964801
• Device Lot Number: 1455627
• 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: 09/23/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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: LAP INSTRUMENTS
• Patient Age: 71 YR
• Patient Sex: Unknown
• Patient Race: White