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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGTOME RX 39 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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BOSTON SCIENTIFIC CORPORATION JAGTOME RX 39 UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00573100
Device Problems Contamination (1120); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 08/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
Note: this report pertains to one of the two devices which were unpacked during the same event. Refer to mfr report# 3005099803-2018-60721 for the first jagtome and mfr report# 3005099803-2018-60722 for the second jagtome. It was reported to boston scientific corporation that a jagtome rx 39 was unpacked on (b)(6) 2018. According to the complainant, it was noticed that two jagtome packages had holes and was confirmed that the sterile barrier was compromised. Reportedly, there was no patient nor procedure involved in the event.
 
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Brand NameJAGTOME RX 39
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 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 Key7938893
MDR Text Key123291220
Report Number3005099803-2018-60721
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/11/2021
Device Model NumberM00573100
Device Catalogue Number47270
Device Lot Number0022368356
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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