MAUDE Adverse Event Report: OTU MEDICAL DISPOSABLE URETEROSCOPE

Catalog Number BDSD01

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that doctor was using one of the disposable scopes that morning and noticed a piece of fiber in the patient.They were able to basket it out.Doctor thought it was a fiber optic from the scope.Per additional information received via sample form on 08may2023, fibers came out of scope suspected fibers in separate bag with return shipment very small.

Event Description

It was reported that doctor was using one of the disposable scopes that morning and noticed a piece of fiber in the patient.They were able to basket it out.Doctor thought it was a fiber optic from the scope.Per additional information received via sample form on 08may2023, fibers came out of scope suspected fibers in seperate bag with return shipment very small.Per follow up via phone on 08jun2023, it was reported that nurse said that they found something but did not know if it was part of the scope or not.

Manufacturer Narrative

The reported event was unconfirmed as the problem could not be reproduced.No root cause was provided as the reported event was unconfirmed.As the reported event was unconfirmed, a device history record review was not required.As the reported event was unconfirmed, a labeling review was not required.H11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the actual/suspected device was inspected.

• Brand Name: DISPOSABLE URETEROSCOPE
• Type of Device: DISPOSABLE URETEROSCOPE
• Manufacturer (Section D): OTU MEDICAL; 2847a whipple road; union city CA 94587
• MDR Report Key: 16963319
• MDR Text Key: 315643881
• Report Number: 1018233-2023-03622
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2023,06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BDSD01
• Device Lot Number: BMGXTU02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/30/2023
• Event Location: Other
• Date Report to Manufacturer: 05/09/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2023
• 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): Required Intervention