MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS02, 5X100 KII SLEEVE ZTHR 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CTS02

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.

Event Description

Procedure performed: laparoscopic sigmoidectomy.Event description: during entry of the trocar, the peritoneum wasn't being penetrated by the obturator, so the surgeon used a grasper to help grasp the distal tip of the trocar while inside of the patient to help the trocar penetrate through the peritoneum.During this process, the tip of the trocar broke off into the patient and the piece could not be found during the procedure.Additional information received from applied medical health system manager, via telephone, on january 28th, 2020: rep.Was present for the case.The event date was january 24th, 2020.The name of the procedure being performed was a laparoscopic sigmoidectomy.The obturator being used was an applied medical obturator.It has been confirmed that the piece of plastic that broke off into the patient was the tip of the cannula.Per rep., the patient was notified that a piece of plastic from the cannula was left in their body.To complete the case, the surgeon replaced the cts02 with another one.There was no patient injury and the product is not expected to return as it was discarded immediately after use.Type of intervention: replaced with another cts02 to complete the case without any further issues.Patient status: no patient injury occurred.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This report is to follow up medwatch report #mw5092690.

Event Description

Procedure performed: laparoscopic sigmoidectomy.Event description: during entry of the trocar, the peritoneum wasn't being penetrated by the obturator, so the surgeon used a grasper to help grasp the distal tip of the trocar while inside of the patient to help the trocar penetrate through the peritoneum.During this process, the tip of the trocar broke off into the patient and the piece could not be found during the procedure.Additional information received from applied medical health system manager, via telephone, on january 28th, 2020: rep.Was present for the case.The event date was january 24th, 2020.The name of the procedure being performed was a laparoscopic sigmoidectomy.The obturator being used was an applied medical obturator.It has been confirmed that the piece of plastic that broke off into the patient was the tip of the cannula.Per rep., the patient was notified that a piece of plastic from the cannula was left in their body.To complete the case, the surgeon replaced the cts02 with another one.There was no patient injury and the product is not expected to return as it was discarded immediately after use.Additional information was received from fda medwatch report, mw# 5092690, via mail on february 20th, 2020: the event date is 24jan2020 and the event report type is serious injury.The event outcome was required intervention.Event description: "during a laparoscopic sigmoid colon resection and fistula take down procedure, the applied medical kii sleeve, item cts02 was removed at the end of the case and revealed an approx 1mm fragment broken of the tip.Pt abdomen was irrigated several times, and unable to locate the plastic fragment.No feedback from rep on what may have caused the break.Fda safety report id# (b)(4)." type of intervention: replaced with another cts02 to complete the case without any further issues.Patient status: no patient injury occurred.

• Brand Name: CTS02, 5X100 KII SLEEVE ZTHR 12/BX
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9677728
• MDR Text Key: 178153069
• Report Number: 2027111-2020-00347
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123499
• UDI-Public: (01)00607915123499(17)221203(30)01(10)1375658
• Combination Product (y/n): N
• PMA/PMN Number: K060096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2022
• Device Model Number: CTS02
• Device Catalogue Number: 101208701
• Device Lot Number: 1375658
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 02/26/2020
• Patient Sequence Number: 1
• Treatment: GRASPER
• Patient Weight: 82