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

Model Number M00519361

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/09/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an orise proknife was used during an unknown procedure performed on (b)(6) 2022. During the procedure, the orise electrode was damaged (with separation). It was not reported if the device was inside the body or in the sheath of the device. The procedure was completed with another orise proknife. There were no patient complications reported as a result of this event.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. (b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

• 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; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14005161
• MDR Text Key: 288662508
• Report Number: 3005099803-2022-01520
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: M00519361
• Device Catalogue Number: 1936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial