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

Model Number M00560160

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that an injection gold probe was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, they advanced a gold probe down the scope.They tried to activate the probe but no energy was getting to the tip of the probe.They removed the probe and used another one, of a different lot number.While advancing down the scope, and the tip of the probe fell off inside the scope.They retrieve the detached piece from the scope using biopsy forceps.The procedure was completed using a third injection gold probe.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: INJECTION GOLD PROBE
• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752-1242 ; 5086834015
• MDR Report Key: 9785170
• MDR Text Key: 190821267
• Report Number: 3005099803-2020-00696
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729056508
• UDI-Public: 08714729056508
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2021
• Device Model Number: M00560160
• Device Catalogue Number: 6016
• Device Lot Number: 0024508910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2019
• 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