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

Model Number GYA-5

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, the reported issue (broken tip) was confirmed.It was observed the tip of the device was broken and cracked.In addition, service found the device was bent.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported the tip of the subject device was broken.The reported event was stated to be found during reprocessing.Additional information has been requested to clarify this statement as the device is a single-use device.There was no patient or user injury reported due to the event.Additional details have been requested regarding the reported issue.At this time, no additional information has been provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h4, h6 and h10.H4: based on the lot number the manufacturing date of the device was in the month of may 2019 but a specific date could not be identified.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 root cause of the broken tip was unable to be identified.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 Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15441347
• MDR Text Key: 305737554
• Report Number: 3003790304-2022-00245
• Device Sequence Number: 1
• Product Code: HCZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT-HIH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• 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: 4840658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• 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