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

Catalog Number HLF-S550-HSMA

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: k124030.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported the cook® single-use holmium laser fiber broke inside the scope.An alternative fiber was opened and used to complete the procedure as intended.There were no adverse consequences to the patient as a result of this reported issue.

Manufacturer Narrative

Investigation ¿ evaluation: the cook® single-use holmium laser fiber was not returned for evaluation.No photographs were provided.Without the complaint device, a physical investigation was not able to be completed.A review of complaint history, the device history record, the instructions for use, manufacturing instructions, quality control data, and trends was conducted.A review of the device history record found no non-conformances related to the fracturing of the laser fiber.A review of complaint history revealed this to be the only complaint associated with lot number 7754382.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; device integrity prior to shipping.This device is shipped with instructions for use (ifu).As found in the precautions section: a number of different factors affect the life of any particular fiber, including: extending lasing at high power.Continuous lasing with the fiber tip in contact with tissue.Improper handling poor lasing beam alignment of focus never subject fiber optics to sharp bends in handling, use, or storage.Always keep connector-end dry and free from contaminants.Discard any fiber optic assembly that is cracked or broken, or does not meet minimum transmission standards.Do not exceed recommended power limits.With the information available the definitive cause of the damaged fiber is undeterminable.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.

• Brand Name: COOK® SINGLE-USE HOLMIUM LASER FIBER
• Type of Device: GEX LASER INSTRUMENT, SURGICAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7384842
• MDR Text Key: 104148036
• Report Number: 1820334-2018-00948
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00827002252967
• UDI-Public: (01)00827002252967(17)200316(10)7754382
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: HLF-S550-HSMA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 03/30/2018
• Supplement Dates Manufacturer Received: 05/10/2018
• Supplement Dates FDA Received: 05/11/2018
• Patient Sequence Number: 1