MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB03, 5X100 KII SH BLD ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTB03
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2020
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.
Event or Problem Description
Procedure performed: robotic assisted laparoscopy, lyse of adhesion, resection of endometriosis.Event description: the rep was not present during the case.During the case two ctb03 trocars were inserted into the patient abdomen.When the camera was inserted into the abdomen and used to examine the abdomen, it was noted that the blades on these two trocars were still engaged and not covered by the shield.The trocars were not removed and were used to complete the case.No patient injury, patient status is fine.Products are available for return.Intervention: continued to use the event trocars.Patient status: no patient injury.
Event or Problem Description
Event 1 of 2: mw # 2027111 - 2020 - 00544.Event 2 of 2: mw # 2027111 - 2020 - 00545.Procedure performed: robotic assisted laparoscopy, lyse of adhesion, resection of endometriosis.Event description: the rep was not present during the case.During the case two ctb03 trocars were inserted into the patient abdomen.When the camera was inserted into the abdomen and used to examine the abdomen, it was noted that the blades on these two trocars were still engaged and not covered by the shield.The trocars were not removed and were used to complete the case.No patient injury, patient status is fine.Products are available for return.Intervention: continued to use the event trocars.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed, as the shield locking mechanism functioned as expected.The event unit met current specification and there were no visible non-conformances.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred based on the evaluation of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: CTB03, 5X100 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: 10483036
• Report Number: 2027111-2020-00544
• Device Sequence Number: 2627044
• Product Code: GCJ
• UDI-Device Identifier: 00607915123512
• UDI-Public: (01)00607915123512(17)230310(30)01(10)1382997
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K072674
• 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): 11/04/2020

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: 03/10/2023
• Device Model Number: CTB03
• Device Catalogue Number: 101138301
• Device Lot Number: 1382997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1