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 Consequences Or Impact To Patient (2199)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: robotic prostatectomy event description: this morning ((b)(6) 2020) the chief of the or told me that on (b)(6) 2020 during a robotic prostatectomy the nurse saw a piece of transparent plastic in the patient's abdomen.Once the piece was extracted it turned out to be one of our trocar seals.Specifically ctb73 lot.1370099.As he has most likely told me there has been an incorrect use of the trocar: it seems the result of an excessive pressure applied by a needle holder on which a needle was mounted.She told me that maybe the needle hooked onto the valve and a strong push on the needle holder caused it to detach.The head nurse made an official report to the [italy] health department for non-compliance of our trocar.The management expects our explanation of what may have happened.Unfortunately the trocar in question has not been kept aside and therefore i cannot send it.Patient status: no patient injury or illness occurred associated with the complaint event.
Event or Problem Description
Procedure performed: robotic prostatectomy.Event description: this morning ((b)(6) 2020) the chief of the operating room told me that on (b)(6) 2020 during a robotic prostatectomy the nurse saw a piece of transparent plastic in the patient's abdomen.Once the piece was extracted it turned out to be one of our trocar seals.Specifically ctb73 lot.1370099.As he has most likely told me there has been an incorrect use of the trocar: it seems the result of an excessive pressure applied by a needle holder on which a needle was mounted.She told me that maybe the needle hooked onto the valve and a strong push on the needle holder caused it to detach.The head nurse made an official report to the [italy] health department for non-compliance of our trocar.The management expects our explanation of what may have happened.Unfortunately the trocar in question has not been kept aside and therefore i cannot send it.Patient status: no patient injury or illness occurred associated with the complaint event.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photo of the event unit was provided by the complainant, which confirmed the complainant's experience of seal component separation.Engineering observed that a part of the shield, a clear plastic component of the seal, was torn.Based on the description of the event and the photo provided, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instruments (needle or needle holder) through the trocar.Applied medical's instructions for use (ifu) states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing.".

• 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: 9700608
• Report Number: 2027111-2020-00355
• Device Sequence Number: 2283964
• Product Code: GCJ
• UDI-Device Identifier: 00607915123727
• UDI-Public: (01)00607915123727(17)221110(30)01(10)1370099
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K072674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

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: 11/10/2022
• Device Model Number: CTB73
• Device Catalogue Number: 101472289
• Device Lot Number: 1370099
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 02/24/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROBOT, NEEDLE HOLDER, NEEDLE; ROBOT, NEEDLE HOLDER, NEEDLE