MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGTOME RX 44 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number 47290

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 07/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported. The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown. (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 a jagtome rx 44 was used in a procedure. According to the complainant, during the procedure, the physician noticed an unusual burn on patient during sphincterotomy. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: JAGTOME RX 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol,; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 7786799
• MDR Text Key: 117219503
• Report Number: 3005099803-2018-60026
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 47290
• Device Catalogue Number: 47290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/15/2018 Patient Sequence Number: 1