MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE DISTAL ATTACHMENT

Model Number D-201-11802

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

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

Event Date 10/16/2023

Event Type  Injury  

Event Description

As reported in a medwatch report 3900900000-2023-8012, a scope cap broke off inside of a patient¿s oral cavity and pharynx and needed to be removed with rat tooth forceps.An additional two caps broke but came out with the scope.The event occurred during an endoscopic gastric peroral myotomy (g-poem) under general anesthesia.No additional information regarding the event was provided.The report is linked to patient identifiers: (b)(6).(broke in scope).

• Brand Name: DISPOSABLE DISTAL ATTACHMENT
• Type of Device: DISPOSABLE DISTAL ATTACHMENT
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• MDR Report Key: 18452392
• MDR Text Key: 332184843
• Report Number: 2429304-2023-00417
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/14/2023,01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-201-11802
• Device Lot Number: 2YK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention