MAUDE Adverse Event Report: INTEGRA YORK PA, INC. RUGGLES KERRISON 1MM; RONGEUR, MANUAL

Model Number 1MM

Device Problem Failure to Cut (2587)

Patient Problem No Information (3190)

Event Date 01/23/2019

Event Type  malfunction  

Event Description

Integra ruggles kerrisons purchased and used.Upon the first time using them, none of them were able to cut tissue.

• Brand Name: RUGGLES KERRISON 1MM
• Type of Device: RONGEUR, MANUAL
• Manufacturer (Section D): INTEGRA YORK PA, INC.
• MDR Report Key: 8292873
• MDR Text Key: 135004619
• Report Number: MW5083545
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 01/28/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1MM
• Device Catalogue Number: RD41191D1
• Device Lot Number: 100161-1803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1