MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET PLUS ASSY, 45 DEGREE X 8MM; LAVAGE, JET

Catalog Number 66800045

Device Problem Improper Flow or Infusion (2954)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2020

Event Type  Injury  

Event Description

It was reported that an experienced doctor in versajet had difficulty getting adequate pressure through the operating window and saline was leaking at the handset connector.The doctor had to abandon the versajet and finished the case with sharp debridement.It is unknown if there was a delay in the procedure.No patient harm reported.

Manufacturer Narrative

The device, which was used in a procedure, was not returned for evaluation.A relationship between the device and the reported incident could not be confirmed, therefore the root cause is undetermined at this time, if the product is returned in the future the complaint can be reopened and evaluated.However factors that are known to contribute to this kind of issue, may include kinks or obstructions in the high pressure tube, or the pinch clamp is not fully open.The ifu has been reviewed and contains comprehensive guides on the operation, use and inspection, including, the associated risk file contains harms related to versajet, however as no harm was alleged within this complaint a review is not required.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found other related failures.Our quality department will continue to monitor for trends.

• Brand Name: VERSAJET PLUS ASSY, 45 DEGREE X 8MM
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10085185
• MDR Text Key: 191967816
• Report Number: 8043484-2020-00543
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 40565124780
• UDI-Public: 40565124780
• Combination Product (y/n): N
• PMA/PMN Number: K110958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800045
• Device Lot Number: 50826696
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/28/2020
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention