MAUDE Adverse Event Report: MEDIVATORS MEDIVATORS JET PREP; JETPREP FLUSHING DEVICE

Model Number JP30022

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 08/14/2014

Event Type  No Answer Provided  

Event Description

The case states that the medivators jetprep water pressure caused minor bleeding and cuts to the colon wall while doing an endoscopy procedure.Patient did not experience any long term injury and was discharged that same day.

Manufacturer Narrative

The case states that the medivators jetprep irrigation tool caused minor bleeding and cuts to the colon wall while doing an endoscopy procedure.This was the first procedure that the physician used the jetprep.Being unfamiliar with its functionality, this may have caused the minor cuts and bleeding due to incorrect positioning/placement.Medivators personnel were present during the procedure and reported that the physician was not concerned with the situation and indicated that the irritation would heal quickly.The patient did not suffer any serious injury or long term side effects as a result.The patient was discharged from the hospital the same day.According to reports, the jetprep did not malfunction and was operating according to specifications.This complaint will continue to be monitored within medivators complaint system.

• Brand Name: MEDIVATORS JET PREP
• Type of Device: JETPREP FLUSHING DEVICE
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 71 ha'nadiv st; herzliya 4648 5; IS 46485
• Manufacturer Contact: megan dickey ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533327
• MDR Report Key: 4068819
• MDR Text Key: 20272071
• Report Number: 1651395-2014-00005
• Device Sequence Number: 1
• Product Code: OCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: JP30022
• Device Lot Number: 22016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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 Age: 60 YR
• Patient Weight: 102