MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE REPOSITIONABLE CLIP; SINGLE USE REPOSITIONAL CLIP

Model Number HX-202UR

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.However, if additional information becomes available or if the device is returned at a later date, this report will be supplemented accordingly.As a preventive measure, the device instruction manual states, ¿always have a spare instrument available¿ in the event that the primary instrument malfunctions.The instruction manual also states that to prevent clip malfunction, ¿never use excessive force to operate the instrument.This could damage the instrument.¿ and ¿do not force the instrument if resistance to insertion is encountered.¿ in addition, there are warnings and cautions that clip operation and closure is more compromised with an excessively angulated scope, firm tissue, or after the clip has been opened / closed more than 5 times.

Event Description

Olympus was informed that during a colonoscopy procedure, the device was deployed and closed, but it would not release.A second clip was used to complete the intended procedure.There was no patient injury reported.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Type of Device: SINGLE USE REPOSITIONAL CLIP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8575744
• MDR Text Key: 143960577
• Report Number: 2951238-2019-00793
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 04953170345180
• UDI-Public: 04953170345180
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-202UR
• Device Lot Number: 8XK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1