MAUDE Adverse Event Report: MEDEGEN MEDICAL PRODUCTS; THERMOMETER, ELECTRONIC, CLINICAL

Device Problems Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/18/2015

Event Type  malfunction  

Event Description

Patient was having a laparoscopic sleeve gastrectomy, after finishing the stapling of the stomach, crna found that the temperature probe was left in and it was determined by the surgeon and anesthesia that it had been stapled across.It was determined that we needed to open at that point.Was able to dislodge probe and restaple.An xray was taken after and reviewed by surgeon and radiologist.

• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): MEDEGEN MEDICAL PRODUCTS; 209 medegen dr.; gallaway TN 38036
• MDR Report Key: 7365065
• MDR Text Key: 103286243
• Report Number: 7365065
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2015,03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/03/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR