MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS GIF-Q180; ENDOSCOPE

Model Number GIF-Q180

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Perforation (2001); Vomiting (2144)

Event Date 08/08/2016

Event Type  Injury  

Event Description

Patient underwent colonoscopy with biopsies and polypectomy.Next day, patient was seen in the ed for abdominal pain and vomiting.X-ray showed free air and was admitted to the hospital.Patient underwent surgery to repair the perforation.Patient is recovering without any sequelae.

• Brand Name: OLYMPUS GIF-Q180
• Type of Device: ENDOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 3500 corporate parkway; center valley PA 18034
• MDR Report Key: 5895907
• MDR Text Key: 52766242
• Report Number: 5895907
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: GIF-Q180
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2016
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 5 YR
• Patient Weight: 22