MAUDE Adverse Event Report: CONSURE MEDICAL PRIVATE LIMITED QORA; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problems Collapse (1099); Difficult to Remove (1528)

Patient Problems Laceration(s) (1946); Blood Loss (2597)

Event Date 04/22/2020

Event Type  malfunction  

Event Description

Patient developed substantial rectal bleeding into and surrounding qora rectal tube.Gi doctor attempted to remove rectal tube to perform colonoscopy but was unable to remove tube.Doctor performed digital exam, in which he described feeling as if the device had rotated to the side and the upper mesh had inverted.He stated that he was able to push the mesh back into position.The qora was then able to be removed and the scope advanced.Doctor stated that there was tissue injury in the rectum obviously caused by the qora mesh.He cauterized portions of the rectum.Per the rn who was present "the device was inserted into the rectum with no issues.However, when we went to remove the green outer piece of the device while holding the white tab it was difficult to remove and the green piece collapsed on itself.After that we were able to remove the green piece.I am assuming that is when the device malfunctioned.".

• Brand Name: QORA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CONSURE MEDICAL PRIVATE LIMITED; 841 rhode island st suite a; san francisco CA 94107
• MDR Report Key: 10051455
• MDR Text Key: 190774202
• Report Number: 10051455
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16425 DA