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

Catalog Number 66800042

Device Problem Failure to Prime (1492)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information: medwatch report mw5094333.

Event Description

It was reported that the product stopped working after being spiked into saline bag, the surgeon stated that this should not be a problem and that meant the device was defective.A new device was opened and worked with no problems.No patient injury reported.Additional information: medwatch report mw5094333.

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, factors that are known to contribute to this kind of issue, may include connection faults, the ifu has been reviewed and contains comprehensive guide on the operation, for use and inspection, including steps to be taken in the event of priming.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.The complaint history file contains further instances of the reported events.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.

• Brand Name: VERSAJET EXACT 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: 10116336
• MDR Text Key: 194118767
• Report Number: 8043484-2020-00624
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 04582111153562
• UDI-Public: 4582111153562
• Combination Product (y/n): N
• PMA/PMN Number: K110958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• 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: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800042
• Device Lot Number: 50838520
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1