MAUDE Adverse Event Report: MOTUS GI MEDICAL TECHNOLOGIES LTD. PURE-VU SYSTEM; COLONOSCOPE AND ACCESSORIES

Model Number	PV-OS-001
Medical Device Problem Code	Inadequate or Insufficient Training (1643)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Dr.(b)(6) performed the procedure after reaching cecum, during withdraw about 30cm into the colon, a small perforation was noticed.The area of perforation had abrasions around it.They sent the patient to x-ray for confirmation of perforation.The tear was closed laparoscopically with no further complications.The patient was released from the hospital 12 hours after the colonoscopy procedure.Perforations are an anticipated risk during colonoscopy, no new safety issue was raised following this event.

• Brand Name: PURE-VU SYSTEM
• Common Device Name: COLONOSCOPE AND ACCESSORIES
• Manufacturer (Section D): MOTUS GI MEDICAL TECHNOLOGIES LTD.; 22 keren ha'yesod st.; tirat carmel, 39026 38; IS 3902638
• MDR Report Key: 7637447
• Report Number: 3011816755-2018-00001
• Device Sequence Number: 1899456
• Product Code: FDF
• UDI-Device Identifier: 05060513700052
• UDI-Public: (01)05060513700052
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 01/10/2019
• Device Model Number: PV-OS-001
• Device Catalogue Number: PV-OS-001
• Device Lot Number: 402454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COLONOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 113