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

Catalog Number	HLF-S365-HSMA
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	08/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k): k124030.The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The area representative reported that the customer called to report there is something inside of the sealed package containing a cook® single-use holmium laser fiber.This device remains unopened and unused.There was no patient contact and no consequences or impact to a patient.
Additional Manufacturer Narrative
Additional information: describe event or problem: a medwatch report was received from the facility on 02oct2017, (b)(4).The medwatch stated, "while opening for a case a piece of back (black per picture provided) debris was noted on the inside of an unopened sterile packer of laser fiber."; investigation summary: a review of the complaint history, device history record, specifications, and a visual inspection of the returned device were conducted during the investigation.One unopened complaint device was returned for investigation.There were no visible anomalies observed with the product or packaging material.Visual examination of the package was performed.Free floating black debris that measured 2mm in width was visualized inside the sealed package.Additionally, a document based investigation evaluation was performed.A review of the device history record found no non-conformances associated with the complaint device lot number.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, the root cause has been attributed to a manufacturing issue.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: COOK® 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: 6828883
• Report Number: 1820334-2017-02778
• Device Sequence Number: 11120545
• Product Code: GEX
• UDI-Device Identifier: 00827002252950
• UDI-Public: (01)00827002252950(17)200508(10)7895411
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

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-S365-HSMA
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1