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

Model Number M00519351

Device Problem Failure to Deliver Energy (1211)

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

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

Block a2: the patient's date of birth is unknown; however, it was reported that the patient was born in 1945.Block h6: imdrf impact code f1001 captures the reportable event of procedure canceled.

Event Description

It was reported to boston scientific corporation that an orise proknife device was used in the esophagus during an endoscopic submucosal dissection procedure performed on (b)(6), 2023.During the procedure, the device could not be energized for an hour.As a result, the procedure has been canceled.There were no patient complications reported as a result of this event.

Manufacturer Narrative

The patient's date of birth is unknown; however, it was reported that the patient was born in 1945.Imdrf impact code (b)(4) captures the reportable event of procedure canceled.Investigation results the returned orise proknife device was analyzed and showed signs of use; however, no visual issues were noted.An electrical test was performed and verified that the device complied with the allowed resistance measurements.The reported impact of absence of treatment corresponds to an event that could not be confirmed by product analysis.The reported event was not confirmed.The device was in good condition, and there were no signs of failure.The manipulation or technique used could have contributed; however, there is no objective evidence to determine that the reported event occurred due to a problem with the returned device.Based on the analysis of the returned device and all the information available, no problem detected was selected as the most probable root cause.

Event Description

It was reported to boston scientific corporation that an orise proknife device was used in the esophagus during an endoscopic submucosal dissection procedure performed on (b)(6) 2023.During the procedure, the device could not be energized for an hour.As a result, the procedure has been canceled.There were no patient complications reported as a result of this event.

• Brand Name: ORISE PROKNIFE
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17605626
• MDR Text Key: 321767817
• Report Number: 3005099803-2023-04494
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729999881
• UDI-Public: 08714729999881
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K200404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00519351
• Device Catalogue Number: 1935
• Device Lot Number: 0030712577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2022
• 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 Age: 78 YR
• Patient Sex: Male
• Patient Weight: 78 KG