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	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: robotic assisted laparoscopic hysterectomy with bilateral salpingectomy.Event description: limited information available at the time of reporting.The rep was not present for the case.For the 2nd trocar used, the blade would not retract.They opened another trocar and completed the case.The rep is confirming if the device was used on the patient.If is unknown at what point in the procedure the un-retracted blade was identified.It was reported that there was no patient injury.The trocars are available for return.Additional information received via email on 18dec2019 from applied medical health systems specialist: "so the information that i received was from the nurse that was giving a break.To answer the questions below: the first trocar did not allow for the blade to be activated.They opened trocar #2.Trocar #2 - the blade did not retract and this was noticed immediately upon insertion.Both devices were used on the patient (no harm was caused to the patient).A 3rd trocar was opened, upon which i found out this trocar also was faulty.This trocar was not originally reported and it was also not identified or kept to be sent back.A 4th trocar (same model & lot number) was used to complete the case.I was told that there have been issue lately at this facility with this specific trocar." additional information received via phone on 18dec2019 at 3:40pm from applied medical health systems specialist: applied medical health systems specialist asked for specifics when she was told that these issues that have been occurring lately at that specific facility as there have been no prior complaints filed by the facility regarding the trocar.She was told by the nurse that she did not have any specific cases, date ranges of the occurrences, estimate of the number of times or any other information as her staff mentioned this in passing and have not been documenting these cases and would not be able to provide anything further.Type of intervention: used another trocar to complete the case.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.The event unit met current specifications 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.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: robotic assisted laparoscopic hysterectomy with bilateral salpingectomy.Event description: limited information available at the time of reporting.The rep was not present for the case.For the 2nd trocar used, the blade would not retract.They opened another trocar and completed the case.The rep is confirming if the device was used on the patient.If is unknown at what point in the procedure the un-retracted blade was identified.It was reported that there was no patient injury.The trocars are available for return.Additional information received via email on 18dec2019 from applied medical health systems specialist: "so the information that i received was from the nurse that was giving a break.[ ] trocar #2 - the blade did not retract and this was noticed immediately upon insertion.Both devices were used on the patient (no harm was caused to the patient).[ ] a 4th trocar (same model & lot number) was used to complete the case.I was told that there have been issue lately at this facility with this specific trocar." additional information received via phone on 18dec2019 at 3:40pm from applied medical health systems specialist: applied medical health systems specialist asked for specifics when she was told that these issues that have been occurring lately at that specific facility as there have been no prior complaints filed by the facility regarding the trocar.She was told by the nurse that she did not have any specific cases, date ranges of the occurrences, estimate of the number of times or any other information as her staff mentioned this in passing and have not been documenting these cases and would not be able to provide anything further.Type of intervention: used another trocar to complete the case.Patient status: no patient injury.

• 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: 9501286
• Report Number: 2027111-2019-00673
• Device Sequence Number: 1304494
• Product Code: GCJ
• UDI-Device Identifier: 00607915123727
• UDI-Public: (01)00607915123727(17)220317(30)01(10)1351226
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/20/2020

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: 03/17/2022
• Device Model Number: CTB73
• Device Catalogue Number: 101219601
• Device Lot Number: 1351226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 02/20/2020
• 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: ROBOT