MAUDE Adverse Event Report: INVUITY, INC EIGR SABER WAVEGUIDE; RETRACTOR, FIBEROPTIC

Catalog Number LAWSON #'S 1911273/349792

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Overheating of Device (1437)

Patient Problem No Information (3190)

Event Date 07/17/2015

Event Type  malfunction  

Event Description

Two light wands were observed to be melting and burning during or procedure, source of problem determined to be the light cord overheating.

• Brand Name: EIGR SABER WAVEGUIDE
• Type of Device: RETRACTOR, FIBEROPTIC
• Manufacturer (Section D): INVUITY, INC; 444 de haro street; san francisco CA 94107
• MDR Report Key: 5112524
• MDR Text Key: 27108597
• Report Number: 5112524
• Device Sequence Number: 0
• Product Code: FST
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/18/2015,09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: LAWSON #'S 1911273/349792
• Device Lot Number: 14100208
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR