MAUDE Adverse Event Report: OLYMPUS OLYMPUS EGD SCOPE; ENDOSCOPE AND ACCESSORIES

Model Number GIF-Q180

Device Problems Device Reprocessing Problem (1091); Detachment Of Device Component (1104); Suction Problem (2170)

Patient Problem Exposure to Body Fluids (1745)

Event Date 03/28/2017

Event Type  Injury  

Event Description

Egd scope in use.Fifth patient this particular scope was used on in 3 month time frame.First use was on (b)(6) 2017.During the use on (b)(6) 2017, loss of suction occurred.Brush used to brush suction side and resolution clip fell out of scope.Scope had been processed and cleaned more than 10 times during this time frame, using aldahol.Tissue sent for dna testing along with 5th patient's blood.Dna did not match as tissue belonged to male and blood belonged to female.Only one male patient had been scoped using this particular egd scope, with 3 female patients to follow him.Egd scope immediately taken out of service on date of event and sent to manufacturer (olympus).State health department notified with determination chances of exposure to infectious disease was very minimal.Letters to be issued to three female patients notifying them of the incident.Manufacturer of resolution clips (boston scientific) also notified of incident.One same date, had hysteroscopy and operative laparoscopy done due to endometrial polypectomy with uterine perforation.Hysteroscopy was planned procedure.

• Brand Name: OLYMPUS EGD SCOPE
• Type of Device: ENDOSCOPE AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS
• MDR Report Key: 6507136
• MDR Text Key: 73374107
• Report Number: MW5069198
• Device Sequence Number: 1
• Product Code: NWB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-Q180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 94