MAUDE Adverse Event Report: OLYMPUS AMERICA INC. QUICKCLIP PRO; ENDO CLIP

Model Number HX-202UR

Device Problems Misfire (2532); Separation Failure (2547)

Patient Problem Inflammation (1932)

Event Type  No Answer Provided  

Event Description

Case of (b)(6) male that came as an outpatient for his colonoscopy on (b)(6) 2017 due to a personal history of colon polyps.Procedure was started at 8:46 am, cecum reached at 8:49 am.During retrieval of scope, noted a polyp (1.0cm) in the ascending colon.It was completely removed without complications by hot snare.To approximate the borders, an olympus clip hx 202ur 58k was used in view that pt was a user of plavix and asa.Clip was deployed but it didn't release from the main port of it.So it was still attached.Multiple attempts were made to detach the clip from the main port being unsuccessful.Called the olympus rep while in the middle of procedure with the assistance of other nurses and md.Despite their recommendations, the clip remained attached and we couldn't detach it from the main port.Their final recommendation was surgery.The clip was even cut at the most proximal part and nothing; finally we were able to push forward the clip, remove the colonoscope and put another thin slim pediatric scope.The clip finally fell off in the attempt of removing the colonoscope.No bleeding was noted and area carefully examined with some inflammation.Another clip was placed, this time boston scientific radial jaw clip without any problems.So this was a close call for possible major complications due to malfunction equipment, this case the olympus clip.According to the end user, this is the third misfired occurrence with this same product and the provider contacted the manufacturer to advise of the other incidences.

• Brand Name: QUICKCLIP PRO
• Type of Device: ENDO CLIP
• Manufacturer (Section D): OLYMPUS AMERICA INC.; 1350 norht meadow pkwy; roswell GA 30076
• MDR Report Key: 6806763
• MDR Text Key: 83239598
• Report Number: MW5071680
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Model Number: HX-202UR
• Device Lot Number: 58K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2017
• 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 Age: 71 YR