MAUDE Adverse Event Report: U&I CORPORATION L'DISQ; ELECTROSURGICAL DEVICE AND ACCESSRIES

Catalog Number	PD02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is the first time after l'disq was released in 2012.About (b)(4) products(l'disq) have been sold until now.Also we have reviewed the device history record(manufacturing & inspection) of l'disq(a18d101).But we could not find any quality problem in dhr.We think that this event was caused by environment of procedure, etc.Via above information.Therefore we will keep monitoring the health status of patient.Remained part of device will be removed from patient's body when he wants to.
Event or Problem Description
This event occurred in (b)(6).The patient had disc disease between l4 and l5 vertebrae.The patient underwent disc decompression procedure on (b)(6) 2018.Part of device(l'disq) was broken off in process of the procedure and remains in the body.Patient does not have any pain.And patient does not want to undergo the removal surgery.Therefore part of device will be removed from patient's body when he wants to.

• Brand Name: L'DISQ
• Common Device Name: ELECTROSURGICAL DEVICE AND ACCESSRIES
• Manufacturer (Section D): U&I CORPORATION; 20, sandan-ro, 76beon-gil; uijeongbu-si, gyeonggi-do 11781 ; KS 11781
• MDR Report Key: 7734130
• Report Number: 9617297-2018-00007
• Device Sequence Number: 2580800
• Product Code: GEI
• UDI-Device Identifier: 08800015900003
• UDI-Public: 08800015900003
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K132797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/17/2020
• Device Catalogue Number: PD02
• Device Lot Number: A18D101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 19 YR