MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH CIRCULAR CUTTING PUNCHES; PUNCH, ENT

Catalog Number WT334945

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/27/2020

Event Type  malfunction  

Event Description

An adult male underwent ent surgery.While using a mushroom punch to widen the sphenoid ostium the head of the mushroom essentially fell off of the instrument and into the left sphenoid sinus.This was noticed when the instrument was withdrawn from the patient.The distal end of the instrument was then identified in the left sphenoid sinus and was successfully removed with a straight suction.The left sphenoid sinus was then inspected again and was found to be empty.This instrument was then marked and passed off the field for discussion with the manufacturer.The surgeon spent approximately 10 minutes looking for and retrieving the missing piece of the punch from the surgical site, prolonging the procedure.There was no identified harm to the patient.The patient discharged home later the same day.

• Brand Name: CIRCULAR CUTTING PUNCHES
• Type of Device: PUNCH, ENT
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; 2400 ringwood ave; san jose CA 95131
• MDR Report Key: 10689779
• MDR Text Key: 211668357
• Report Number: 10689779
• Device Sequence Number: 1
• Product Code: KTF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2020,09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WT334945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12410 DA
• Patient Weight: 77