MAUDE Adverse Event Report: GYRUS ACMI, INC DOUBLE END CURETTE

Model Number 130147

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

At the time of this report, the device has not yet been returned for evaluation.As a result, a determination cannot be made at this time.If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.

Event Description

Product broke during operation.A piece of the product fell into the patient.The piece could be taken out of the patient.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results.The device was returned to the service center for evaluation.Upon receiving the component, a test was performed against the unbroken curette end, and the bar began to displace when 15 lbs was applied to the curette tip.The tip did not break at that level of applied force, and per our voice of the customer ( marketing) normal use of the instrument would not apply that great of a force, this seems to be an isolated incident.The failure could not be replicated, and no cause could be determined.The only conclusion is that the device may have being used in an unintended manor which caused the failure.Complaint history report was reviewed and the failure mode has not occurred frequently enough to require corrective action.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information regarding dhr review performed.The oem performed a review of the device history record (dhr) and found no anomalies during the manufacturing of the subject device and lot number.

• Brand Name: DOUBLE END CURETTE
• Type of Device: DOUBLE END CURETTE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 7433726
• MDR Text Key: 106042258
• Report Number: 1037007-2018-00002
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT-LRC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130147
• Device Lot Number: SD635085
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/16/2018
• Supplement Dates Manufacturer Received: 05/23/2018; 05/23/2019
• Supplement Dates FDA Received: 08/12/2019; 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention