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

Catalog Number	HLF-S550-HSMA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2017
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 cook single-use holmium laser fiber was brittle.When it was inserted into the scope the fiber bent back and broke.This occurred prior to patient contact.No unintended section of the device remained inside the patient¿s body.No additional procedures were required due to this product issue.A new fiber was put in the laser and the procedure was completed.Additional patient and event details have been requested.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the cook® single-use holmium laser fiber was not returned.Photographs were not provided.Without the actual device, a physical examination could not be performed.A review of the complaint history, the device history record, and specifications was conducted.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.A review of the device history record found no non-conformances associated with the complaint device lot number.A review of complaint history found no other complaints have been received against this complaint device lot number.Based on the provided information the definitive root cause for the fiber breakage could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.Appropriate personnel have been notified of this event.
Additional Manufacturer Narrative
One opened cook single-use holmium laser fiber package labeled rpn hlf-s550-hsma, label lot number 8037369 was received.There was no quartz extending from the distal tip.Under magnification the blue cladding has a melted appearance.At 2.3 cm from the distal tip the quartz was broken and separated.Inside the cladding had a charred appearance and was separated.The quartz was not visible from the point of separation.The fiber plug was secure.Based on the evidence presented by the sample and previous information already provided, a definitive root cause could not be established.

• 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: 7041613
• Report Number: 1820334-2017-03924
• Device Sequence Number: 2036675
• Product Code: GEX
• UDI-Device Identifier: 00827002252967
• UDI-Public: (01)00827002252967(17)200703(10)8037369
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2018

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: No Information
• Device Catalogue Number: HLF-S550-HSMA
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 12/08/2017; 02/26/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 12/12/2017; 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1