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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
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COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER Back to Search Results
Catalog Number 519650
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/22/2023
Event Type  malfunction  
Manufacturer Narrative
The lot number was reviewed for complaint trend, non-conforming report and capa.Devices met specification prior to release and no trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
 
Event Description
According to available information, this device required replacement due to a break.After the case started, the first device was opened.During the case, when the surgeon was inserting the device onto the trocar tip, the tip broke off.Neither of the trocars was used on the patient, and the device was never implanted in the patient.Another device was opened and implanted.No other adverse patient effects were reported.
 
Manufacturer Narrative
Two introducers were received for evaluation.Examination of the right introducer revealed the tip to be detached and not returned.Microscopic examination of the detachment end of the right introducer revealed the detachment site to be rough and irregular, indicating stress was exerted.No abnormalities were noted with the left introducer.The information received indicated during the procedure the tip of the introducer broke off.The introducer tip may bend if it is pushed onto something hard such as bone, which indicates the introducer may not have been in the proper place to insert the anchor.A review of the device history record by the contract manufacturer confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
 
Event Description
According to available information, this device required replacement due to a break.After the case started, the first device was opened.During the case, when the surgeon was inserting the device onto the trocar tip, the tip broke off.Neither of the trocars was used on the patient, and the device was never implanted in the patient.Another device was opened and implanted.No other adverse patient effects were reported.
 
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Brand Name
ALTIS SINGLE INCISION SLING SYSTEM
Type of Device
FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
Manufacturer (Section D)
COLOPLAST A/S
1 holtedam humlebaek, dk 3050
humlebaek 3050
DA  3050
Manufacturer (Section G)
MINNEAPOLIS
1 holtedam humlebaek, dk 3050
humlebaek 3050
DA   3050
Manufacturer Contact
usbes brian schmidt
1601 west river road n
minneapolis, MN 55411
MDR Report Key17770549
MDR Text Key323679518
Report Number2125050-2023-01138
Device Sequence Number1
Product Code PAH
Combination Product (y/n)N
PMA/PMN Number
K121562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/08/2024
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 Catalogue Number519650
Device Lot Number8812214_5196502400
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/18/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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