MAUDE Adverse Event Report: HOLOGIC, INC. HOLOGIC TUBE SET; INSUFFLATOR HYSTEROSCOPIC

Lot Number 4013788

Device Problem Protective Measures Problem (3015)

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

Event Date 10/08/2018

Event Type  malfunction  

Event Description

Patient presented for elective same day procedure.Outflow tubing sensor failed, which is used to monitor output.This was noticed when the pump alarm sounded.After troubleshooting, the tubing was replaced and the incident was reported to manufacturer.The output monitoring was done manually in the interim.There was no harm to the patient.Operations manager and clinical coordinator aware and following up.

• Brand Name: HOLOGIC TUBE SET
• Type of Device: INSUFFLATOR HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; unk
• MDR Report Key: 7956460
• MDR Text Key: 123801797
• Report Number: MW5080469
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/09/2018

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 Lot Number: 4013788
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2018
• 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
• Patient Age: 48 YR