MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 QUANTAHOLMIUMLASERFIBER; LASER FIBER

Catalog Number OAF702711

Device Problem Material Fragmentation (1261)

Patient Problem Burn(s) (1757)

Event Date 12/28/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the doctor was lasering a kidney stone in the lower pole of the kidney and the laser fiber broke on the outside of the scope by the accessory port.The doctor was using a 272 fiber and the fiber burned the doctors wrist.No medical intervention was reported.

Manufacturer Narrative

¿upon further review, bd has determined that this mdr was initially reported in error.Bd does not hold the regulatory approval for this product.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

Event Description

It was reported that the doctor was lasering a kidney stone in the lower pole of the kidney, and the laser fiber broke on the outside of the scope by the accessory port.The doctor was using a 272 fiber, and the fiber burned the doctor's wrist.No medical intervention was reported.

• Brand Name: QUANTAHOLMIUMLASERFIBER
• Type of Device: LASER FIBER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16223560
• MDR Text Key: 308633821
• Report Number: 1018233-2023-00204
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OAF702711
• Device Lot Number: A221709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2023
• 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
• Patient Outcome(s): Other