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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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BOSTON SCIENTIFIC CORPORATION LYNX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR Back to Search Results
Model Number M0068503000
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/02/2018
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 a lynx system was about to be used on a mid-urethral sling procedure performed on (b)(6) 2018.According to the complainant, before the procedure started, the seal of the packaging was partially opened.There was no visible damage on the box before it was opened.The procedure was completed with another lynx system.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Problem code 1444 captures the reportable event of unsealed device packaging.An examination was performed.The tray, containing the mesh assembly and delivery device, was returned, with the lid partially opened.No damage was noted to the mesh assembly and delivery device inside of the tray.Witness marks were noted around the tray's perimeter, indicating that the package was sealed.On one section of the tray, there appeared to be less traces of adhesive, and appears scraped off.The device was further analyzed.The tyvek lid did not reveal to have any "hot" spots or voided areas.The scraped marks on the tray flange are likely not a result of the manufacturing process.Each tray is inspected for voids and pits; if defective, the tray is replaced and the device is re-sealed with a new tray.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.The investigation concluded that the most probable cause for this event is cause not established, which indicates that the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.
 
Event Description
It was reported to boston scientific corporation that a lynx system was about to be used on a mid-urethral sling procedure performed on (b)(6) 2018.According to the complainant, before the procedure started, the seal of the packaging was partially opened.There was no visible damage on the box before it was opened.The procedure was completed with another lynx system.There were no patient complications reported as a result of this event.
 
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Brand Name
LYNX SYSTEM
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8120323
MDR Text Key128909034
Report Number3005099803-2018-61575
Device Sequence Number1
Product Code OTN
UDI-Device Identifier08714729718949
UDI-Public08714729718949
Combination Product (y/n)N
PMA/PMN Number
K020110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/13/2019
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 Health Professional
Device Expiration Date07/25/2021
Device Model NumberM0068503000
Device Catalogue Number850-300
Device Lot Number0022430262
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2018
Initial Date Manufacturer Received 11/04/2018
Initial Date FDA Received11/30/2018
Supplement Dates Manufacturer Received01/16/2019
Supplement Dates FDA Received02/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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