MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068403930
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device component code relates to device problem code for the evaluation findings of debris on the fiber face within the sma connector.(b)(6).Investigation results one flexiva 550 laser fiber was received for evaluation.Visual examination revealed that the exposed glass fiber tip measured approximately 3.5 mm and appeared used.Additional examination under magnification revealed that the fiber tip was slightly degraded.There was no damage along the body of the fiber.Visual examination of the fiber face within the sma connector under magnification revealed a debris on the fiber face and that only a small amount of light is coming through.This would cause the device to emit insufficient energy transmission during ablation thereby confirming the event.The noted damages indicate the complaint was caused by handling of the device or portion of the device without direct patient contact either during unpacking, preparation, or shipping; at the end of the procedure; or when packaging for return.Therefore, a review and analysis of all available information indicated that the most probable root cause is handling damage.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that a flexiva 550 laser fiber was used in a procedure performed on (b)(6) 2017.Reportedly, the laser unit used was an auriga xl laser console and it was unknown if the laser console has been rfid modified to be used with flexiva laser fibers.According to the complainant, during preparation and outside the patient, the laser fiber stopped firing energy after 10 to 15 minutes of use.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that there were debris on the fiber face within the sma connector.Please refer to block h10 for full investigation details.
Additional Manufacturer Narrative
Conclusion and result codes updated.Investigation results: one flexiva 550 laser fiber was received for evaluation.Visual examination revealed that the exposed glass fiber tip measured approximately 3.5 mm and appeared used.Additional examination under magnification revealed that the fiber tip was slightly degraded.There was no damage along the body of the fiber.Visual examination of the fiber face within the sma connector under magnification revealed a debris on the fiber face and that only a small amount of light is coming through.This would cause the device to emit insufficient energy transmission during ablation thereby confirming the event.The noted damages indicate difficulty was experienced during the procedure and are likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that a flexiva 550 laser fiber was used in a procedure performed on (b)(6) 2017.Reportedly, the laser unit used was an auriga xl laser console and it was unknown if the laser console has been rfid modified to be used with flexiva laser fibers.According to the complainant, during preparation and outside the patient, the laser fiber stopped firing energy after 10 to 15 minutes of use.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that there were debris on the fiber face within the sma connector.

• Brand Name: FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7281978
• Report Number: 3005099803-2018-00281
• Device Sequence Number: 10798982
• Product Code: GEX
• UDI-Device Identifier: 08714729808206
• UDI-Public: 08714729808206
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K100078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2020
• Device Model Number: M0068403930
• Device Catalogue Number: 840-393
• Device Lot Number: C000004220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1