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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER OBTRYX II SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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BOSTON SCIENTIFIC - SPENCER OBTRYX II SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Model Number M0068504110
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device has been received for analysis.Upon 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.
 
Event Description
It was reported to boston scientific corporation that an obtryx ii system was used during a sling procedure on an unknown date.According to the complainant, during procedure, "the device broke." it is unknown what part of the device broke and how it broke, and attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.The event description may suggest that the device handle had detached or separated from the needle.The procedure was completed with another obtryx ii system.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.Should additional relevant details become available, a supplemental report will be submitted.
 
Event Description
It was reported to boston scientific corporation that an obtryx ii system was used during a sling procedure on an unknown date.According to the complainant, during procedure, "the device broke." it is unknown what part of the device broke and how it broke, and attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.The event description may suggest that the device handle had detached or separated from the needle.The procedure was completed with another obtryx ii system.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.Should additional relevant details become available, a supplemental report will be submitted.
 
Manufacturer Narrative
A visual examination of the returned obtryx ii system revealed that the handles were returned with the dilators attached to them by their association loops.The association loops were removed and replaced with no issue.There was no damage to either delivery device.The sleeves were cut.The mesh was stretched on one end.The centering tab was still attached.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.Based on all gathered information and investigation results, there is no evidence of either the alleged issue or any defect which could have contributed to the event.Therefore, the assigned complaint investigation conclusion code for this event is undeterminable.
 
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Brand Name
OBTRYX II SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
Manufacturer (Section D)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
MDR Report Key7641066
MDR Text Key112432588
Report Number3005099803-2018-02011
Device Sequence Number1
Product Code OTN
UDI-Device Identifier08714729839255
UDI-Public08714729839255
Combination Product (y/n)N
PMA/PMN Number
K121754
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date08/13/2020
Device Model NumberM0068504110
Device Catalogue Number850-411
Device Lot Number21005807
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2018
Initial Date Manufacturer Received 05/31/2018
Initial Date FDA Received06/27/2018
Supplement Dates Manufacturer Received06/28/2018
Supplement Dates FDA Received07/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age77 YR
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