MAUDE Adverse Event Report: COLOPLAST A/S ALTIS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number 519650

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/10/2020

Event Type  malfunction  

Event Description

Altis sling trocar tip broke off inside the patient.Surgeon asked for x-ray to be performed in pacu instead of the or as it would cause more harm to retrieve the retained item.The x-ray confirmed a 6-7mm radiopaque metallic density.

• Brand Name: ALTIS
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): COLOPLAST A/S; 1601 west river road north; minneapolis MN 55411
• MDR Report Key: 10239599
• MDR Text Key: 197779954
• Report Number: 10239599
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: (01)05708932467407
• 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: 06/26/2020

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 Model Number: 519650
• Device Catalogue Number: 519650
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Weight: 75