MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT CANISTER 1200CC GUARDIAN; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	65651-212
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported they received two cases of suction canisters where the boxes were damaged upon breaking down their pallet.They were not noticed as the boxes were in the middle.The product looked usable but on multiple occasions they stopped working mid procedure during various planned gastrointestinal procedures.There was a 1-2 minute delay to switch out the canisters.Event date is unknown.No demographics were provided.No injury to patient.Patient reported doing fine.
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Additional Manufacturer Narrative
Supplemental report is being filed following the submission of the initial mdr report submitted on 4/25/2022 due to the investigation results are available.Device history record (dhr) of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.A sample was not provided for evaluation; therefore, an evaluation of the complaint device for deficiency of construction could not be performed.We are unable to determine a specific assignable cause for the reported incident.If the canister had a crack before applying suction, this would prevent the unit from functioning as intended.Per the directions for use included with the product, canisters, lids, and components should be inspected for damage from shipping, storage, or handling prior to use.We will continue to monitor trends for this product.

• Brand Name: CANISTER 1200CC GUARDIAN
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• Manufacturer (Section G): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 14197350
• Report Number: 1423537-2022-00755
• Device Sequence Number: 14763873
• Product Code: GCX
• UDI-Device Identifier: 50630140152533
• UDI-Public: 50630140152533
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

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 Model Number: 65651-212
• Device Catalogue Number: 65651-212
• Device Lot Number: J112-046
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown