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

Model Number	CTS02
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9558255
• Report Number: 2027111-2020-00301
• Device Sequence Number: 2375403
• Product Code: GCJ
• UDI-Device Identifier: 00607915123499
• UDI-Public: (01)00607915123499(17)220606(30)01(10)1359322
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• 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
• Report Date (Section B): 01/07/2020

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1