MAUDE Adverse Event Report: UNKNOWN TISSUE RETRIEVAL SYSTEM 8MM; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number TRS-ROBO-8

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/31/2022

Event Type  malfunction  

Event Description

Bag was being removed out of patient and string broke inside patient.The ag was then inside the patient.Dr.(b)(6) was able to use a kelley to grab bag to remove from patient.

• Brand Name: TISSUE RETRIEVAL SYSTEM 8MM
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15744631
• MDR Text Key: 303278709
• Report Number: MW5113104
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/31/2022

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 Catalogue Number: TRS-ROBO-8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White