MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCVE REPL, 5:4 HD CPLR, AC; INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE

Catalog Number 72200315S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/19/2014

Event Type  malfunction  

Event Description

It was reported the deivce could not be seen through.

• Brand Name: SCVE REPL, 5:4 HD CPLR, AC
• Type of Device: INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon dr.; austin, TX 78735
• MDR Report Key: 6947624
• MDR Text Key: 89975310
• Report Number: 3003604053-2017-00129
• Device Sequence Number: 1
• Product Code: FEI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/13/2017

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 Catalogue Number: 72200315S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 10/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1