MAUDE Adverse Event Report: MEDIGUS LTD MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE

Model Number SRS05

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 11/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).This mdr was originally submitted on december 9, 2016, but it was not accepted because it was submitted as an xml file instead of a zip file.

Event Description

It was brought to our attention that on (b)(6) 2016, during the preparation stage for a muse procedure and after the insertion of the overtube, the physician noticed a possible laceration of the esophageal wall.The physician decided to place a stent.The muse procedure was cancelled and the endostapler was discarded.

• Brand Name: MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE
• Type of Device: ENDOSTAPLER
• Manufacturer (Section D): MEDIGUS LTD; 7a industrial park; pob 3030; omer, israel 84965 00; IS 8496500
• Manufacturer (Section G): MEDIGUS LTD.; 7a industrial park; pob 3030; omer, israel 84965 00; IS 8496500
• Manufacturer Contact: ronen cohen ; 7a industrial park; p.o.b. 3030; omer, 84965 ; IS 84965 ; 9725435163
• MDR Report Key: 6170928
• MDR Text Key: 62267382
• Report Number: 3004444684-2016-00004
• Device Sequence Number: 1
• Product Code: ODE
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K132151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/25/2018
• Device Model Number: SRS05
• Device Catalogue Number: MMAA10060000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/14/2016
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2016
• 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