MAUDE Adverse Event Report: EVONOS GMBH & CO. KG CIRCULAR CUTTING PUNCHES; PUNCH, ENT

Catalog Number WT334945

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Per mr (b)(4), an adult male underwent ent surgery.While using a mushroom punch to widen the sphenoid.Ostium the head of the mushroom essentially fell of the instrument and into the left sphenoid sinus.This was noticed when the instrument was withdraw from the patient.The distal end of the instrument was then identified in the left sphenoid sinus and was successfully removed with the straight suction.The left sphenoid sinus was then inspected again and was found to be empty.This instrument was then marked and passed of the field for discussion with the manufacture.The surgeon spent approximately 10min looking for and retrieving the missing piece of the punch from the surgical site, prolonging the procedure.There wsa no identified harm to the patient.The patient discharged home later that same day.

• Brand Name: CIRCULAR CUTTING PUNCHES
• Type of Device: PUNCH, ENT
• Manufacturer (Section D): EVONOS GMBH & CO. KG; stockacher str.; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: thomas hoffmann ; stockacher strasse 134; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 10947909
• MDR Text Key: 240279569
• Report Number: 3010726901-2020-00001
• Device Sequence Number: 1
• Product Code: KTF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2020

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: WT334945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 77