MAUDE Adverse Event Report: GYRUS ACMI, INC. 5FR GRASPER FORCEP; HYSTEROSCOPE (AND ACCESSORIES)

Model Number GYA-5

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/30/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus that the tip of the 5fr grasper forcep fell off inside the patient during a therapeutic procedure (removal of an intrauterine device) and the pieces could not be found for retrieval.Additional information indicated that the patient would be coming back for an xray as they were concerned what type of metal the grasper is made with.Additional information has been requested but not received.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, since the subject device was not returned to olympus, an evaluation could not be performed.Therefore, the root cause of the reported event (broken device/ fell into paptient) could not be determined.This supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: 5FR GRASPER FORCEP
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18375690
• MDR Text Key: 331129090
• Report Number: 3003790304-2023-00455
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

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: GYA-5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention