MAUDE Adverse Event Report: COVIDIEN MANSFIELD UNKNOWN TRUCLEAR DEVICE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number UNKNOWN TRUCLEAR DEVICE

Device Problem Incorrect Measurement (1383)

Patient Problems Uterine Perforation (2121); Abdominal Distention (2601); No Code Available (3191)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, after a hysterectomy and polypectomy, and all the instruments were removed from vagina, the cervix was noting to be hemostatic.They noted that the abdomen to be markedly distended.They calculated a fluid deficit of 375 ml.Due to abdominal distention, a diagnostic laparoscopy was performed, intra-abdominal survey revealed copius amount of clear fluid as well as right-sided fundal perforation that was noted to be hemostatic with a small clot overlying it.The clot was removed, and again hemostasis was observed.An absorbable hemostatic particle were applied to ensure excellent hemostasis.Suction irrigator was utilized to remove as much fluid from the abdomen as possible.Approximately 1, 000 ml of fluid was removed, revealing a mark discrepancy between actual and machine calculated fluid deficit.The patient was admitted to the hospital for 23-hour observation.

• Brand Name: UNKNOWN TRUCLEAR DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN MANSFIELD; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN MANSFIELD; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 10112338
• MDR Text Key: 193607715
• Report Number: 1282497-2020-00016
• 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: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN TRUCLEAR DEVICE
• Device Catalogue Number: UNKNOWN TRUCLEAR DEVICE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 78