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	06/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The event was reported within a clinical study (irb id #: (b)(4)) as an anticipated event.After anesthesia wore off, patient complained of abdominal pain.X-rays showed free air; an exploratory laparoscopy was performed along with repair of perforation.A 1 cm injury was found at the rectosigmoid junction of the colon and this was repaired with suturing.The patient tolerated the procedure well and discharged 2 days after the operation with no further complications.The event may be related to the retroflex attempts that physician made during the procedure.Perforations are an anticipated risk during colonoscopy where retroflex is known to elevate such risks particularly in a narrow anatomy; issue will continue to be trended.

• 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: 7678091
• Report Number: 3011816755-2018-00002
• Device Sequence Number: 1554481
• Product Code: FDF
• UDI-Device Identifier: 05060513700052
• UDI-Public: (01)05060513700052
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2018

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: No Information
• 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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 07/11/2018
• 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: 63 YR
• Patient Weight: 74