MAUDE Adverse Event Report: MITG - RF SURGICAL SYSTEMS SITUATE; COUNTER, SPONGE, SURGICAL

Model Number 01-0030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the case started as a laparoscopic assisted right colectomy that converted to open.Sponge was left in and was removed at a different hospital because the patient had a previously scheduled abdominal surgery where in the sponge was identified.During that surgery, the sponge was removed.The patient did not have any infection, sepsis, or encephalopathy.

• Brand Name: SITUATE
• Type of Device: COUNTER, SPONGE, SURGICAL
• Manufacturer (Section D): MITG - RF SURGICAL SYSTEMS; 2101 faraday; carlsbad CA 92008
• Manufacturer (Section G): MITG - RF SURGICAL SYSTEMS; 2101 faraday; carlsbad CA 92008
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 8354448
• MDR Text Key: 136718217
• Report Number: 3005883396-2019-00013
• Device Sequence Number: 1
• Product Code: LWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-0030
• Device Catalogue Number: 01-0030
• Device Lot Number: 136C9R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 89