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 Date 08/01/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned for evaluation.The cause of the issue is unknown at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported that during a hysteroscopy the alligator forceps had broke and was retrieved.There was no patient harm, no user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response to follow up and the legal manufacturer's final investigation.Communication with the customer, conveyed the following information: customer stated that the device will not be returned.According to the customer, when olympus was contacted regarding the alligator forceps that a piece broke off during a procedure, he was advised that the forceps could not be repaired.Customer stated that the piece that broke off was retrieved (procedure was a hysteroscopy, the surgeon visualized the forceps break and was able to retrieve the piece).Customer disposed the broken forceps and the piece when the new forceps arrived.Physical evaluation of the device cannot be performed as the customer is not returning the subject device.A probable cause is difficult to determine with the limited available information.The device history record (dhr) cannot be completed as the serial number is not available and the device was not returned.Complaint history review was performed and found zero (none) currently opened or closed corrective action preventive action (capa) for model gya-5.Olympus will continue to monitor complaints for this device.Supplemental report(s) will be submitted should any relevant new information is available and or received.

• 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: 15306763
• MDR Text Key: 305244127
• Report Number: 3003790304-2022-00175
• 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: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• 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