MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number D2201

Device Problem Unsealed Device Packaging (1444)

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

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.The device packaging was not returned for evaluation therefore analysis on the packaging could not be performed.As a result, the allegation of the packaging seal being broken could not be confirmed.The device did return.Visual and functional tests were done on the device and no abnormalities were noted.Based on this investigation, the conclusion code of cause not established was chosen because the information provided is not sufficient to determine the most probable cause of the reported issue related to the packaging.

Event Description

It was reported that just before a convective radiofrequency water vapor thermal therapy procedure, the seal of the packaging for the delivery device was observed to be partially open.A second device was opened and used to complete the procedure successfully without any complications to the patient.

Event Description

It was reported that just before a convective radiofrequency water vapor thermal therapy procedure, the seal of the packaging for the delivery device was observed to be partially open.A second device was opened and used to complete the procedure with no issues.

Manufacturer Narrative

The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.The device packaging was not returned for evaluation therefore analysis on the packaging could not be performed.As a result, the allegation of the packaging seal being broken could not be confirmed.The device did return.Visual and functional tests were done on the device and no abnormalities were noted.Based on this investigation, the conclusion code of cause not established was chosen because the information provided is not sufficient to determine the most probable cause of the reported issue related to the packaging.

• Brand Name: REZUM
• Type of Device: UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11402103
• MDR Text Key: 239577113
• Report Number: 3001236349-2021-00005
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729992547
• UDI-Public: 08714729992547
• Combination Product (y/n): N
• PMA/PMN Number: K191505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

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 Expiration Date: 08/18/2022
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 0026326234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1