MAUDE Adverse Event Report: ENDOCHOICE, INC. FUSE ENDOSCOPY SYSTEM; GASTROSCOPE AND ACCESSORIES

Model Number FUSE 1G

Device Problems Material Fragmentation (1261); Mechanical Jam (2983)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/20/2017

Event Type  Injury  

Manufacturer Narrative

The gastroscope and the detached piece of plastic were returned to the manufacturer service center for evaluation.It was determined that a raised ridge from the transition ring at the end of the gastroscope's biopsy channel caught and sheared off a piece of plastic sheathing from the forceps during channel passage, which subsequently moved from the channel to the patient during the procedure.No information regarding the forceps used was provided after repeated contacts with the report source.The raised ridge on the transition ring was found to be caused by improper installation of the transition ring during a repair which took place (b)(6) 2017.Review of complaint records show no other occurences of a similar sequence of events.Device repair included repair of the biopsy channel transition ring, replacement of the ccd camera assembly, and replacement of the bending sheath on the distal tip.

Event Description

It was reported that during a gastroscopy case, the physician experienced resistance in the biopsy channel when passing a forcep; after the forcep passed through the device, a piece of plastic was discovered inside the patient.According to the report, the physician was able to retrieve the plastic piece during the procedure and no further intervention was required.

• Brand Name: FUSE ENDOSCOPY SYSTEM
• Type of Device: GASTROSCOPE AND ACCESSORIES
• Manufacturer (Section D): ENDOCHOICE, INC.; 11810 wills road; alpharetta GA 30009 2081
• Manufacturer (Section G): ENDOCHOICE, INC.; 11810 wills road; alpharetta GA 30009 2081
• Manufacturer Contact: daniel hoefer ; 11810 wills road; alpharetta, GA 30009-2081 ; 6787084743
• MDR Report Key: 6504934
• MDR Text Key: 73193721
• Report Number: 3007591333-2017-00025
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 04/19/2017

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
• Device Operator: Health Professional
• Device Model Number: FUSE 1G
• Device Catalogue Number: FSG-2500-ST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2017
• Initial Date FDA Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 106