MAUDE Adverse Event Report: MANUAL SURGICAL SCIENCES, LLC DV8 ESOPHAGEAL RETRACTOR; DV8 RETRACTOR

Model Number 14075150

Device Problem Use of Device Problem (1670)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Ulcer (2274); Injury (2348)

Event Date 11/02/2017

Event Type  Injury  

Manufacturer Narrative

The dv8 retractor is a class i 510k exempt device under product code gad (retractor) which falls under regulation 21 cfr 878.4800 as a "manual surgical instrument for general use.".

Event Description

It was reported that upon completion of an atrial fibrillation procedure with general anesthesia on (b)(6) 2017, the patient experienced bleeding.Uninterrupted eliquis (5 mg twice daily) was given.The dv8 device was employed to displace the esophagus to the right to allow bilateral pv isolation; however, it was reported that the device was advanced deeper, so that injection of contrast into the proximal injection port would exit the distal aspect of the esophagus.The patient remained stable throughout the case.Upon completion of the case, the dv8 device was removed and blood-stained secretions were noted in the oral cavity.A nasogastric tube was inserted and 150 cc of blood was aspirated from the stomach.Intravenous vasopressors and fluid resuscitation were administered; the patient was immediately given 1 unit of packed red blood cells and stabilized.An endoscopy was performed that day, but the findings were poor quality.It appeared there was an area of ulceration and active bleeding.A ct scan of the chest revealed no evidence of a perforation.As no further intervention was performed that day, the patient was brought to the cardiac care unit.A repeat endoscopy was done the following day, and no evidence of any esophageal bleeding, tears or trauma was found.The stomach did have evidence of two superficial linear tears in the gastric cardia from trauma.Mild oozing with a small adherent clot was noted.The clot was removed.The patient was then extubated after the second endoscopy.The patient did well and was discharged on post-procedure day #2.It was concluded that the trauma likely occurred as a result of the distal portion of the dv8 device being inserted into the stomach.If additional information is provided, a follow up report will be sent.

• Brand Name: DV8 ESOPHAGEAL RETRACTOR
• Type of Device: DV8 RETRACTOR
• Manufacturer (Section D): MANUAL SURGICAL SCIENCES, LLC; 2303 kennedy street ne; suite 100; minneapolis MN 55413
• Manufacturer Contact: jim webb ; 2303 kennedy st. ne; suite 100; minneapolis, MN 55413 ; 6128442554
• MDR Report Key: 7054648
• MDR Text Key: 92833492
• Report Number: 3011596926-2017-00003
• Device Sequence Number: 1
• Product Code: GAD
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2017

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: 14075150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 76