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

Catalog Number 104015

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2015

Event Type  malfunction  

Event Description

It was reported via user facility medwatch: "a plastic piece from the lighted illumination (waveguide) retractor broke off during surgery.".

Manufacturer Narrative

The product was not returned to the manufacturer and no lot number was provided.Batch record review was not able to be performed since no lot number was provided.No further investigation can be performed.There was no patient injury involved as reported by the user facility.

• Brand Name: EIGR WAVEGUIDE
• Type of Device: RETRACTOR, FIBEROPTIC
• Manufacturer (Section D): INVUITY INC.; san francisco CA 94107
• Manufacturer Contact: john kang ; 444 de haro st; san francisco, CA 94107
• MDR Report Key: 4922547
• MDR Text Key: 6436364
• Report Number: 3011394215-2015-00001
• 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: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 104015
• Device Lot Number: NP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2015
• 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
• Patient Age: 52 YR
• Patient Weight: 65