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

Model Number HX-202UR

Device Problems Detachment Of Device Component (1104); Positioning Failure (1158)

Patient Problem Blood Loss (2597)

Event Date 10/05/2017

Event Type  Injury  

Manufacturer Narrative

The clip was not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.A potential cause is operator¿s technique.The instruction manual states that the clip should not be advanced abruptly, rotated while against tissue, or forcibly inserted, or else damage to the clip or patient injury may occur.Furthermore, the clip should not be repositioned more than five times, otherwise the clip may fail to open while grasping tissue.The instruction manual also contains preventive warnings and cautions regarding bleeding: ¿¿clip performance for hemostasis is limited.Prepare more than one hemostatic device and select appropriate hemostatic device or use it together to respond to different hemorrhage situations¿, and ¿use this instrument in an environment equipped to accommodate open surgery.¿.

Event Description

Olympus was informed that at the beginning of an upper endoscopy procedure to treat a bleeding ulcer, two clips failed to grip the duodenal tissue at deployment.This resulted in mild bleeding and one day hospitalization of the patient.There was no report of the clips breaking or falling into the patient.The procedure was completed with similar devices from a different manufacturer.This is report 1 of the 2 clips involved in this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the original equipment manufacturer (oem).The oem reviewed the device history record for the lot and confirmed that the lot had passed final inspection before release.The oem also stated that a possible failure mode is that the limiter broke during excess angulation of the endoscope, preventing clip arm retraction and interfering with clip release.

• 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
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6983405
• MDR Text Key: 90424967
• Report Number: 2951238-2017-00704
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK123601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: HX-202UR
• Device Catalogue Number: HX-202UR
• Device Lot Number: 72K
• Other Device ID Number: 04953170345180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2018
• 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
• Patient Outcome(s): Hospitalization
• Patient Weight: 93