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  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported via a medwatch report, that the disposable distal scope cap broke off inside of a patient's oral cavity and the pharynx needed to be removed with rat tooth forceps.Two additional caps broke, but came out with the scope.The issue was found during a therapeutic endoscopic gastric peroral endoscopic myotomy (g-poem) procedure.The patient was under anesthesia.There were no reports of patient harm.This report is related to the following linked patient identifiers: (b)(6) (fell in patient) and (b)(6) (broke in scope).

Manufacturer Narrative

This supplemental report is to provide a correction to the pervious initial report mdr as a non-reportable malfunction was reported.The initial medwatch reported that during a therapeutic endoscopic gastric peroral endoscopic myotomy (g-poem) procedure two additional caps broke but came out with the scope.The patient was under anesthesia and there were no reports of patient harm.The broken cap inside the scope is not considered life-threatening, nor did it lead to a permanent impairment in the patient.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18438462
• MDR Text Key: 331901892
• Report Number: 9614641-2024-00013
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170048395
• UDI-Public: 04953170048395
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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 Model Number: D-201-11802
• Device Lot Number: 2YK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1