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 01/14/2020

Event Type  malfunction  

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 Description

Procedure performed: roux n y.Event description: rep was not present for the case.When inserting the obturator, a distal piece of the cannula broke off.The piece was retrieved and replaced with a new trocar to complete the case.The cts02 was used as a secondary lateral port using bladed obturator for insertion.There was no patient injury.The device is available to be returned.Additional information received via email on 17jan2020 from applied medical account mgr: the procedure was "roux n y.No lot number was saved".Intervention: the piece was retrieved and replaced with a new trocar to complete the case.Patient status: fine.

Event Description

Procedure performed: roux n y.Event description: rep was not present for the case.When inserting the obturator, a distal piece of the cannula broke off.The piece was retrieved and replaced with a new trocar to complete the case.The cts02 was used as a secondary lateral port using bladed obturator for insertion.There was no patient injury.The device is available to be returned.Additional information received via email on 17jan2020 from applied medical account mgr: the procedure was "roux n y.No lot number was saved" intervention: the piece was retrieved and replaced with a new trocar to complete the case.Patient status: fine.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection of the returned unit confirmed that the tip of the cannula was melted and deformed.Engineering was able to replicate the damage by heating an instrument and touching the tip of the cannula on a representative test unit.Based on the condition of the returned unit and replication testing, it is likely that the reported event was caused by a heat-producing instrument that made contact with the tip of the cannula during the procedure.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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: 9623824
• MDR Text Key: 176984023
• Report Number: 2027111-2020-00330
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CTS02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1