MAUDE Adverse Event Report: GYRUS ACMI, INC. 5FR GRASPER FORCEP

Model Number GYA-5

Device Problem Material Twisted/Bent (2981)

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

Event Date 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation was not confirmed.The evaluation findings were as follows: the shaft of the grasper forceps appeared slightly bent near the handle, the bottom jaw of the distal end was missing and had not been returned with the device, and there were sharp edges on a certain portion where the bottom jaw should have been located.The evaluation found no dents or chips, and the condition of the jaw was still intact and was able to be moved up and down with handle manipulation.The investigation is ongoing and follow-up with the user facility is currently being performed.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 to olympus that the clamp on the end of the single use 5fr grasper forcep was not aligned.The issue was found as the device was taken out of the box, and there was no patient harm associated with the event.The device was returned and evaluated; the shaft of the grasper forceps appeared slightly bent near the handle.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information provided by the customer: b5/event description: the customer reported that there was no procedural or patient involvement associated with the event.

Event Description

The customer reported that there was no procedural or patient involvement associated with the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the definitive root cause of the deformation could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: 5FR GRASPER FORCEP
• Type of Device: GRASPER FORCEP
• 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: 15835424
• MDR Text Key: 307785348
• Report Number: 3003790304-2022-00308
• Device Sequence Number: 1
• Product Code: HCZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT-HIH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GYA-5
• Device Lot Number: 5209240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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