MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. BIOPSY VALVE

Model Number MB-358

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

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

Event Date 09/28/2023

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus for evaluation.During the evaluation, the customer's original reported issue of a broken lid on the forceps stopper was confirmed.The damaged forceps stopper was also reproduced.Based on the results of the investigation, fracture surface analysis confirmed that the lid of the biopsy valve was torn from the inner surface side to the outer surface.Although the cause cannot be determined, it is presumed that the crack occurred when the syringe was withdrawn.Based on the information that the fluid was pumped with a syringe while the lid of the biopsy valve was covered.It is speculated that the forceps plug may have been torn off due to excessive external stress caused by forcible insertion of the syringe into the slit of the biopsy valve.Therefore, it is assumed that part of the torn lid fell into the body.Based on the results of the investigation, the root cause of the event was unable to be specified.A review of the device history record (dhr) was unable to be confirmed since the actual item was provided as a subject device, and the lot number and manufacturing date was not known.Operation manual of an endoscope chapter 4 ¿operation¿ section 4.2 ¿insertion¿ warns for subject event as below.*it is mainly stated for the endoscope gif-h190 that the subject facility owns is described.Air/water feeding and suction feeding liquid through the instrument channel.When using a syringe to inject liquid through the biopsy valve, insert the syringe straight into the biopsy valve.Otherwise, patient fluids and/or debris may leak or spray from the biopsy valve, and it may cause an infection control risk.When using a syringe to inject liquid through the biopsy valve, detach the valve¿s cap from the main body.Then insert the syringe into the valve.Otherwise, the biopsy valve could be damaged, and the syringe could be detached from the valve.Also, patient fluids and/or debris may leak or spray from the biopsy valve, and it may cause an infection control risk.Olympus will continue to monitor the field performance of this device.

Event Description

A user facility reported when they inserted the semi-disposable forceps plug (mb-358) into the forceps from above the lid (without opening the lid), part of the lid of the forceps plug broke and fell into the patient's body.The event occurred during an upper endoscopy.The damaged lid was recovered and there was no health hazard to the patient.

• Brand Name: BIOPSY VALVE
• Type of Device: BIOPSY VALVE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18577094
• MDR Text Key: 333659570
• Report Number: 9610595-2024-01585
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170063947
• UDI-Public: 04953170063947
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MB-358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: GIF-H190.; GIF-H190N.
• Patient Outcome(s): Required Intervention