MAUDE Adverse Event Report: GYRUS ACMI, INC. 200 MICRON TFL SINGLE USE FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number TFL-FBX200S

Device Problem Break (1069)

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

Event Date 01/28/2024

Event Type  malfunction  

Event Description

It was reported that the single use fiber broke in the distal operating channel of the flexible ureteroscope equipment during a urologic procedure.The broken piece was retrieved resulting in a procedural delay of 5 minutes.There is no evidence that the broke into the patient but noted that the device broke into the distal operating channel.While there was a 5 mins delay there were no health hazards reported because of the short delay and no evidence that the patient was at risk for injury or, any missed critical diagnosis/treatment.There was no evidence of any serious deterioration in the state of health of the patient.There is no report that a life-threatening event occurred, that the malfunction caused or contributed to a permanent impairment in the patient.There is no evidence that the patient developed a permanent disability or permanent damage that caused substantial disruption in the state of heath of the patient, and that additional medical or surgical intervention was required to preclude permanent impairment of a body function or damage to a body structure that is associated with the use of the olympus device.

Manufacturer Narrative

To date, the device has not been returned.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This report is being supplemented to provide additional information.Updated field: d9 the device was returned and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 200 MICRON TFL SINGLE USE FIBER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• 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: 18718136
• MDR Text Key: 335958296
• Report Number: 3003790304-2024-00020
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K183647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

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: TFL-FBX200S
• Device Lot Number: KR348608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 02/20/2024
• 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
• Treatment: FLEXIBLE URETEROSCOPE EQUIPMENT (URF-V3)
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 102 KG