MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH NASAL SCISSORS; SCISSORS, GENERAL, SURGICAL

Catalog Number WT441500

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 02/12/2019

Event Type  malfunction  

Event Description

Double action scissor blade broke off while doctor was using it in the nose.Associate nurse manager and team leader was notified.Instrument was removed from sterile field.

• Brand Name: NASAL SCISSORS
• Type of Device: SCISSORS, GENERAL, SURGICAL
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8743941
• MDR Text Key: 149515150
• Report Number: 8743941
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/25/2019

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: WT441500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8760 DA
• Patient Weight: 93