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

Model Number HX-202UR

Device Problem Failure to Discharge (1169)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

Five clips from this lot were returned to olympus for evaluation by the user facility.A visual inspection was performed on the received condition of the clip; there was no missing parts as the clip portion was intact with the device.The distal tip was checked and noted that the clip inside the device has not been deployed.During testing, when the handle was manipulated, the clip failed to deploy.The insertion portion was inspected and there are no external damages.The slider was manipulated and the movement is normal.Based on the investigation results, the complaint is confirmed.The cause of the reported ¿failed to deploy¿ could not be determined at this time.The device will be forwarded to the original equipment manufacturer (oem) for further investigation.If additional information becomes available, this report will be supplemented accordingly.The instruction manual provides warning to mitigate the risk of patient injury and device damage that states, ¿keep the insertion portion of the instrument that extends from the biopsy valve and the insertion portion of the endoscope as straight as possible.Do not perform clipping with the insertion section being coiled.Otherwise, the force exerted on the control section may not convey to the clip adequately during clipping.This could result in reduced performance, making it impossible to close the clip or detach it from the coil sheath after clipping.When forcing the clip against the tissue, do not try to rotate the clip.Doing so may tear tissue inside the body cavity, resulting in patient injury, such as perforation, bleeding, or mucous membrane damage.Do not try to forcibly remove the clip if it becomes caught on the distal end of the coil sheath.Forcible removal of the clip could cause patient injury such as perforation, bleeding, or mucous membrane damage.¿.

Event Description

The manufacturer was informed that the doctor was performing a colonoscopy when five clips failed to deploy.The doctor was unable to finish the case and cancelled the procedure.Additional information received indicated as a result of the failed clips, sedation was reversed and the patient was transferred to post anesthesia care unit (pacu).Additional clips became available approximately 2 hours after the patient woke up.The patient was transferred back to the procedure room and sedated.The doctor placed one clip in the patient successfully to completed the procedure.The patient did not have any pre-existing conditions and there were no further complications.The user facility reported the devices and equipment were inspected prior to procedure but no anomalies were noted.This is report 1 of 5.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Type of Device: SINGLE USE REPOSITIONABLE 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: 8637804
• MDR Text Key: 145991947
• Report Number: 2951238-2019-00865
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HX-202UR
• Device Lot Number: 88K 06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: SCOPE: OLYMPUS CF-HQ190L, SERIAL # (B)(4); SINGLE USE REPOSITIONABLE CLIP X 4
• Patient Outcome(s): Other