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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.
 
Manufacturer Narrative
Block h6 (device codes): the problem code 1120 captures the reportable event of device not sterile.Block h10: visual examination of the returned unit revealed that the device was on its original pouch, sealed and closed.The pouch was found tore, specifically the tyvek and clear plastic.There were no other defects noted.The complaint was consistent with the reported event of packaging tore.It is possible that the way in which the device was handled and manipulated may have contributed to the failure encountered.There is no control of how the unit was stored and handled at the field, it is the most likely that the device could be handled improperly causing the damage encountered (pouch tear) this defect could be traced to transport or storage problems due to mishandling and not a manufacture related issue.Therefore, a conclusion code of cause traced to transport/storage was assigned to this complaint since problems traced to the inappropriate transport or storage of the device.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.
 
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 Name
JAGTOME RX 39
Type of Device
UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key7938893
MDR Text Key123291220
Report Number3005099803-2018-60721
Device Sequence Number1
Product Code KNS
UDI-Device Identifier08714729776536
UDI-Public08714729776536
Combination Product (y/n)N
PMA/PMN Number
K013153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/12/2018
1 Device was Involved in the Event
1 Patient was 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 Health Professional
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
Date Manufacturer Received10/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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