MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB73, 12X100 KII SH BLD ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTB73
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
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.This report is to follow-up medwatch #(b)(4).
Event or Problem Description
Procedure performed: "laparoscopy with lysis of adhesions and bilateral salpingo-oophorectomy".Event description: medwatch received via mail on 20apr2021 mw # (b)(4): "an elderly female underwent laparoscopy with lysis of adhesions, and bilateral salpingo-oophorectomy.During procedure, trocar top popped off several times.The shaft appeared to be the defect.No harm to patient." additional information received via email on 21apr2021 from [user facility]: procedure was completed with "new trocar used.Did not deploy correctly." the non-conformance was identified, "while it was being used." there are no photos available of the device.Additional information received via email on 22apr2021 from [user facility]: "the new trocar used to complete case worked fine, the reference of "did not deploy correctly" was in regards to event trocar that didn't work properly." it is unknown if the new trocar was the same model and lot.The new trocar worked appropriately.Patient status: "no harm to patient".
Event or Problem Description
Procedure performed: "laparoscopy with lysis of adhesions and bilateral salpingo-oophorectomy" event description: medwatch received via mail on 20apr2021 mw # (b)(4): "an elderly female underwent laparoscopy with lysis of adhesions, and bilateral salpingo-oophorectomy.During procedure, trocar top popped off several times.The shaft appeared to be the defect.No harm to patient." additional information received via email on 21apr2021 from [user facility]: procedure was completed with "new trocar used.Did not deploy correctly." the non-conformance was identified, "while it was being used." there are no photos available of the device.Additional information received via email on 22apr2021 from [user facility]: "the new trocar used to complete case worked fine, the reference of "did not deploy correctly" was in regards to event trocar that didn't work properly." it is unknown if the new trocar was the same model and lot.The new trocar worked appropriately.Patient status: "no harm to patient.".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the returned unit, which confirmed that the seal could be removed without pressing the cannula wing tabs.The distance between the wing tabs was measured and was undersized.Based on the condition of the returned unit and event description, it is likely that the seal housing separated from the cannula due to undersized wing tab distance.The exact root cause of the undersized wing tab distance is unknown.Seal dislodgement from the cannula is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow up medwatch # (b)(4).

• Brand Name: CTB73, 12X100 KII SH BLD ZTHR 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 11732176
• Report Number: 2027111-2021-00467
• Device Sequence Number: 4427069
• Product Code: GCJ
• UDI-Device Identifier: 00607915123727
• UDI-Public: (01)00607915123727(17)231009(30)01(10)1399417
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 10/09/2023
• Device Model Number: CTB73
• Device Catalogue Number: 101219601
• Device Lot Number: 1399417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR