MAUDE Adverse Event Report: GIVEN IMAGING / MEDTRONIC (GIVEN IMAGING) MANOSCAN ESO CATHETER; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number ESO CATHETER MSC-3890-Z.

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 esophageal catheter model #msc-3890-z.Mfr's reprocessing instructions are not current with va standards and current regulatory (e.G., no precleaning or pre-treatment instructions; calibration of probe ifu's, disposable sheath that may or may not be used (contingent if it's for an impedance study-not-stated in ifu) attaches "use disinfectant wipe, talc," this then goes into pt.Ifu states soaking but no manual wiping or sponging to manual cleaning probe-this has several ridges on items, improper storage, plastic storage box does not have any instructions how to clean or high level disinfect, is not vented for continuous air flow).The company has been contacted and won't provide anything more/further clarification.

• Brand Name: (GIVEN IMAGING) MANOSCAN ESO CATHETER
• Type of Device: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): GIVEN IMAGING / MEDTRONIC; mansfield MA 02048
• MDR Report Key: 8078443
• MDR Text Key: 127856158
• Report Number: MW5081371
• 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: ESO CATHETER MSC-3890-Z.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: 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