MAUDE Adverse Event Report: COOK INC OPTILITE SINGLE-USE HOLMIUM LASER FIBER; GEX LASER INSTRUMENT, SURGICAL

Catalog Number	HLF-S273-CNV
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that during a lithotripsy procedure, a small amount of glass flaked off the end of the fiber.The doctor could not see a glass particle and did not know whether it was vaporized.They continued with the procedure and did not remove any glass pieces.There were no injuries to the patient and no additional medical intervention.
Additional Manufacturer Narrative
Investigation summary: based on the physical investigation, one open package was received.Under magnification damage to the fiber tip was observed.Fiber was returned to the supplier for evaluation.Based on the supplier investigation, the product inspection result and initial product evaluation findings show the fiber to be in good working condition.Based on the findings, the fiber is not a nonconforming product.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the available information, the root cause of this event is undeterminable.This complaint is confirmed based on the customer's testimony, and a physical evaluation of the returned product.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: OPTILITE SINGLE-USE HOLMIUM LASER FIBER
• Common Device Name: GEX LASER INSTRUMENT, SURGICAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6731587
• Report Number: 1820334-2017-01825
• Device Sequence Number: 1243811
• Product Code: GEX
• UDI-Device Identifier: 00827002486140
• UDI-Public: (01)00827002486140(17)200417(10)7837206
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K073496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: HLF-S273-CNV
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1