MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SLING; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC FOR STRESS URINARY INCONTINENCE FEMALE

Model Number 519650

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2019

Event Type  malfunction  

Event Description

Patient had a combination surgery robotic xi hysterectomy and robotic xi tape sling.The sling was a coloplast altis sling.When the physician used the grasping teeth that hold the sling in place.The grasping teeth broke off in the patient and could not be found.A second sling was used.When the physician pulled on the mesh the suture piece disconnected from the mesh and could not be used.It was removed without difficulty.A third sling was used and it worked correctly.The grasping teeth that fell off are meant to be in the patient and the physician and coloplast representative stated that there would be no harm to the patient.Manufacturer response for altis sling, altis sling (per site reporter).Sales representative was in the room and stated that there would be no harm to the patient.

• Brand Name: ALTIS SLING
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC FOR STRESS URINARY INCONTINENCE FEMALE
• Manufacturer (Section D): COLOPLAST A/S; 1601 west river road; minneapolis MN 55411
• MDR Report Key: 9676548
• MDR Text Key: 177977158
• Report Number: 9676548
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 519650
• Device Lot Number: 6684422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13870 DA
• Patient Weight: 165