MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY LINVATEC 10K100 ARTHR.TUBE SET; ARTHROSCOPE

Model Number	10K100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported on behalf of the customer that the device, 10k100, linvatec 10k100 arthr.Tube set was being used on (b)(6) 2022 and " during a laparoscopic surgery, while a surgeon was doing irrigation, a white debris was found.It was removed from a patient's body and also there was no impacts on the patient.This 10k100 was disposed of at the hospital.¿ there was no impact or injury to the patient or user.There was no report of medical intervention or any prolonged hospitalization for the patient.The procedure was completed with an alternate same device with a 2 minute delay.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Additional fda product code: gcj.Manufacturer narrative: reported event is inconclusive.The device is not being returned and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.A two-year lot history review was conducted and found a total of 2 similar events involving 2 devices for this lot number.(b)(4).Per the instructions for use, the user is advised the following: tubing sets should only be used if the original packaging and labeling are intact.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: LINVATEC 10K100 ARTHR.TUBE SET
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 14747451
• Report Number: 3007305485-2022-00076
• Device Sequence Number: 5158761
• Product Code: HRX
• UDI-Device Identifier: 10845854041208
• UDI-Public: (01)10845854041208(17)260905(30)1(10)202109065
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K033573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2022

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: 09/05/2026
• Device Model Number: 10K100
• Device Catalogue Number: 10K100
• Device Lot Number: 202109065
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic