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

Catalog Number 66800045

Device Problems Improper Flow or Infusion (2954); Pressure Problem (3012)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

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 used/intended to be used in treatment has not been returned for evaluation, with no additional information provided.We have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.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, 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, this investigation is now complete with no further action deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.F blanks were filled by mistake.

• 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: 10085172
• MDR Text Key: 191967588
• Report Number: 8043484-2020-00542
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

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: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention