MAUDE Adverse Event Report: OLYMPUS SURGICAL TECHNOLOGIES AMERICA OLYMPUS; ENDOSCOPIC BITE BLOCK

Model Number MAJ-1632

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tooth Fracture (2428)

Event Date 03/12/2019

Event Type  malfunction  

Event Description

From staff: patient had documented bonded front tooth prior to procedure on the anesthesia record.When patient woke from procedure she informed recovery nurse that her tooth was broken.Certified registered nurse anesthetist and procedure doctor were informed and came to post op and examined and spoke to patient.Charge nurse and department head were aware.Patient stated that her tooth had been repaired several years ago.Patient had a bite block inserted before the esophagogastroduodenoscopy, the scope inserted through the bite block and the bite block taken out after the procedure.Patient taken to post op.

• Brand Name: OLYMPUS
• Type of Device: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): OLYMPUS SURGICAL TECHNOLOGIES AMERICA; 2400 ringwood ave.; san jose CA 95131
• MDR Report Key: 8513569
• MDR Text Key: 141920553
• Report Number: 8513569
• Device Sequence Number: 1
• Product Code: MNK
• 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: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MAJ-1632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Weight: 91