MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SKW DEEP SCROTALRETRACTABLE SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE

Model Number 72403867

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2023

Event Type  malfunction  

Event Description

It was reported that, during an inflatable penile prosthesis implant surgery, the medical staff noted that there was a hair under the plastic tray of this skw deep scrotal retract system; therefore, a different skw was used to complete the procedure.There were no patient complications reported.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, the returned component underwent a thorough analysis.The hooks were visually inspected.No damage or abnormalities were identified.Based on the information available and analysis results, the reported clinical observation of a hair under the plastic tray of this skw deep scrotal retract system could not be confirmed; therefore, a conclusion code of caused not established was assigned to this investigation.

• Brand Name: SKW DEEP SCROTALRETRACTABLE SYSTEM
• Type of Device: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18185868
• MDR Text Key: 329320035
• Report Number: 2124215-2023-65568
• Device Sequence Number: 1
• Product Code: OTM
• UDI-Device Identifier: 60888937012400
• UDI-Public: 60888937012400
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2023

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: 72403867
• Device Catalogue Number: 72403867
• Device Lot Number: 9338010431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Race: White