MAUDE Adverse Event Report: INVUITY, INC. EIGER WAVEGUIDE; RETRACTOR, FIBEROOPTIC

Catalog Number 104015

Device Problems Break (1069); Component Falling (1105); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 01/15/2016

Event Type  malfunction  

Event Description

During breast surgery, the resident noticed the lighted breast retractor that had been working prior was not working properly.Upon further inspection, it was observed that a piece of the waveguide had broken off.The broken piece had fallen into the patient, but was removed.There was no harm to patient and this is a near miss with potential for harm if staff had not found broken plastic piece.

• Brand Name: EIGER WAVEGUIDE
• Type of Device: RETRACTOR, FIBEROOPTIC
• Manufacturer (Section D): INVUITY, INC.; 444 de haro street; san francisco CA 94107
• MDR Report Key: 5398189
• MDR Text Key: 37072820
• Report Number: 5398189
• Device Sequence Number: 1
• Product Code: FDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: 104015
• Device Lot Number: AB15102402
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2016
• 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
• Treatment: NONE KNOWN
• Patient Age: 59 YR
• Patient Weight: 83