MAUDE Adverse Event Report: GYRUS ACMI, INC. USA ELITE RIGID OPTICAL GRASPING FORCEPS; FORCEPS, GENERAL & PLASTIC SURGERY

Model Number E8215

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 08/08/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus.The medwatch mw5144679 is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Event Description

Olympus received a medwatch mw5144679 indicating that the usa elite rigid optical grasping forceps broke in the patient while the physician was in the process of removing a stent during a therapeutic left lower extremity popliteal thrombectomy and angiogram.The small metal piece was then retrieved.Multiple fogartys were opened to complete the procedure.The patient condition and procedural outcome were not impacted and no additional medical treatment was required.There was no further harm or user injury reported due to the event.

Event Description

No error messages that may have been observed as a result of the failure.The procedure was not prolonged.The procedure did not need to be cancelled or postponed.The procedure was completed with multiple fogartys.The reported problem did not affect the diagnostic or therapeutic outcome of the procedure.No other devices connected to the subject device when the failure occurred.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.The device history record was unable to be reviewed for this device since the serial 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 and investigation results of the past, it is likely the suggested event occurred due to application of excessive force at the device handles or twisting/bending the instrument while grasping a stationary object.However, the subject device was not returned and the root cause of the suggested event could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: USA ELITE RIGID OPTICAL GRASPING FORCEPS
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• 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: 17855668
• MDR Text Key: 324741324
• Report Number: 3003790304-2023-00381
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 00821925001244
• UDI-Public: 00821925001244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT-GEN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E8215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2023
• 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