MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET EXACT ASSY, 45 DEGREE X 14MM; LAVAGE, JET

Catalog Number 66800041

Device Problems Failure to Prime (1492); Obstruction of Flow (2423)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2020

Event Type  malfunction  

Event Description

It was reported that in a versajet ii exact disposable handpiece 45 degree x 14 mm, the saline flow did not come out from the tip of the handpiece when using the product.Procedure was finished with the same device.No harm or injury reported on patient.A 30 minutes or less delay was reported.

Manufacturer Narrative

H3, h6: the device used in treatment was returned for evaluation.A relationship between the reported event and device could be established.A visual inspection was performed and showed no blockage was observed at the distal output orifice.The piston assembly was in the middle position within the chamfer.Functional inspection was performed and showed there was no water flow as the feed line was connected to the water supply.The device was manually primed, and the device functioned as intended.Probable root cause may be an obstruction in the fluid supply.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.A complaint review indicated other failures reported.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for adverse trends related to this product.

• Brand Name: VERSAJET EXACT ASSY, 45 DEGREE X 14MM
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10816308
• MDR Text Key: 215498277
• Report Number: 8043484-2020-03798
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: K110958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800041
• Device Lot Number: 50714732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1