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

Model Number CTS02

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

The event unit was returned to applied medical for evaluation, along with an additional trocar unit and a small piece of metal.No damages or physical non-conformances were observed on both of the units that were returned.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the origin of the small piece of metal or confirm that a product malfunction occurred, as the returned applied medical trocars do not have any metal components.

Event Description

Procedure performed: unknown.Event description: a small piece of metal was found inside the sleeve.Limited information was available at the time of reporting.An email is available that states that yes, the problem could cause harm.Additional information from applied medical representative via email on october 3, 2019: gbmc report of product failure form provided: "small piece of metal found inside trocar".Yes, in the reporters opinion the problem could cause harm to employee or patient.Type of intervention: unknown.Patient status: unknown.

• 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
• Manufacturer Contact: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 9558255
• MDR Text Key: 177624942
• Report Number: 2027111-2020-00301
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123499
• UDI-Public: (01)00607915123499(17)220606(30)01(10)1359322
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2022
• Device Model Number: CTS02
• Device Catalogue Number: 101208701
• Device Lot Number: 1359322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1