MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS02, 5X100 KII SLEEVE ZTHR 12/BX; GCJ

Model Number	CTS02
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	03/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.
Event or Problem Description
Procedure performed: bilateral oophorectomy.Event description: the trocar broke off and a piece fell into the patient's abdomen.The piece was removed using graspers.The piece was clear in color.This was a piece of the inner seal.They were using [an energy device] at the time of the event.This occurred around the middle of the procedure.The device was removed and replaced with another applied medical trocar.There was no patient injury.The device is available for return.Additional information was received via telephone on 03/25/2019 at 8:14am from materials manager: the event date was (b)(6) 2019 and the distributor that they used for the trocar was [].Patient status: no patient injury occurred associated with the complaint event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of seal component separation.The shield, a clear plastic component of the seal and the septum, a rubber internal component of the seal, were damaged.Based on the condition of the returned unit and the description of the event, it is likely that the torn septum and dislodged shield were caused by non-axial insertion or removal of asymmetrical instrumentation through the trocar.Applied medical¿s instructions for use 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." applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
Event or Problem Description
Procedure performed: bilateral oophorectomy.Event description: the trocar broke off and a piece fell into the patient's abdomen.The piece was removed using graspers.The piece was clear in color.This was a piece of the inner seal.They were using [an energy device] at the time of the event.This occurred around the middle of the procedure.The device was removed and replaced with another applied medical trocar.There was no patient injury.The device is available for return.Additional information was received via telephone on (b)(6) 2019 at 8:14am from materials manager: the event date was (b)(6) 2019 and the distributor that they used for the trocar was [].Patient status: no patient injury occurred associated with the complaint event.

• Brand Name: CTS02, 5X100 KII SLEEVE ZTHR 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8501433
• Report Number: 2027111-2019-00415
• Device Sequence Number: 2689205
• Product Code: GCJ
• UDI-Device Identifier: 00607915123499
• UDI-Public: (01)00607915123499(17)211108(30)01(10)1341026
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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: Other
• Device Expiration Date: 11/08/2021
• Device Model Number: CTS02
• Device Catalogue Number: 101208701
• Device Lot Number: 1341026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIGASURE.