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

Model Number 66800041

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 07/23/2017

Event Type  malfunction  

Event Description

It was reported at first, it comes out very well.After a certain period of use, it is sprayed like a sprayer.

• Brand Name: VERSAJET II EXACT 45DEG X 14MM
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU32B N; UK HU32BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 76. s meridan avenue; oklahoma city OK 73107
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6803063
• MDR Text Key: 83118380
• Report Number: 8043484-2017-00206
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K110958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

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
• Device Operator: Health Professional
• Device Model Number: 66800041
• Device Catalogue Number: 66800041
• Device Lot Number: 50654451
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/18/2017
• Supplement Dates Manufacturer Received: 07/24/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1