MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HEDGEHOG; ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Model Number SBD-289-50

Device Problem Break (1069)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

D4: this is a non-sterile device with no expiration date.H6: imdrf device code a0401 captures the reportable event of brush break.

Event Description

It was reported to boston scientific corporation that a hedgehog double-end brush was used during a scope cleaning on march 01, 2024.During scope cleaning, the brush broke off in the scope.The detached brush was retrieved from the scope.The scope cleaning was completed using a different brush.There was no patient involvement in this event.

Manufacturer Narrative

Block d4: this is a non-sterile device with no expiration date.Block h6: imdrf device code a0401 captures the reportable event of brush break.Block h11: additional information: block b5 has been updated based on the additional information that a scope cleaning was completed using another of the same device and the detached brush came out of the scope via the processing machine.

Event Description

It was reported to boston scientific corporation that a hedgehog double-end brush was used during a scope cleaning on (b)(6) 2024.During scope cleaning, the brush broke off in the scope.The detached brush was retrieved from the scope.The scope cleaning was completed using a different brush.There was no patient involvement in this event.Additional information received on march 28, 2024: the scope cleaning was completed using another of the same device.In addition, it was reported that the processing machine pushed the detached brush out of the scope.

• Brand Name: HEDGEHOG
• Type of Device: ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): CHANGZHOU TEMEIRUI MEDICAL; building 34 no 249; middle liangchan; changzhou, 100 21320 0; CH 213200
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18974836
• MDR Text Key: 338761035
• Report Number: 3005099803-2024-01209
• Device Sequence Number: 1
• Product Code: MNL
• UDI-Device Identifier: 00816849010090
• UDI-Public: 00816849010090
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SBD-289-50
• Device Catalogue Number: 60252
• Device Lot Number: 0000230811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• 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