MAUDE Adverse Event Report: GIVEN IMAGING / MEDTRONIC MANOSCAN AR 3D PROBE (AND RECTAL CATHETER); SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number AR 3D CATHETER MSC-3885-3D

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Manoscan ar rectal probe catheter model #msc-3885-3d.Mfr's reprocessing instructions are not current with va standards and current regulatory standards (e.G., on precleaning or pre-treatment instructions; calibration of probe ifu's, disposable sheath that attaches "use disinfectant wipe, talc," this then goes into pt.If sheath is compromised the item will potentially backflow with pt body fluids through the lumen and potentially leach to the next pt due to improper cleaning if the lacking ifu is followed.Ifu states soaking ubt no bruising or manual cleaning of lumen, improper storage (luer lock holder that could harbor moisture in the lumen as it blocks the very small channel), plastic storage box does not have any instructions how to clean or high level disinfect, is not vented for the channels to have a continuous air flow).The company has been contacted and won't provide anything more/further clarification.Also, irrigation catheter that runs through the catheter and appears to be disposable, however, it is not and is impossible for it to be cleaned appropriately.

• Brand Name: MANOSCAN AR 3D PROBE (AND RECTAL CATHETER)
• Type of Device: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): GIVEN IMAGING / MEDTRONIC; mansfield MA 02048
• MDR Report Key: 8078475
• MDR Text Key: 127855318
• Report Number: MW5081373
• Device Sequence Number: 1
• Product Code: FFX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR 3D CATHETER MSC-3885-3D
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1