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

Model Number N/A

Device Problem Device Damaged Prior to Use (2284)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 05/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 Description

The customer reported that the cook® single-use holmium laser fiber was found broken when the package was opened.The device did not come in contact with the patient.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.No additional information has been provided at this time.

Manufacturer Narrative

Investigation ¿ evaluation: a review of complaint history, the device history record, instructions for use (ifu), manufacturing instructions, specifications, quality control and a visual inspection of the returned device was conducted.The opened cook single-use holmium laser fiber package (labeled rpn hlf-s200-hsma, lot 7444819) was received.The fiber was returned inside the packaging tray and protective coil.The fiber was not secured inside the coil when received.When removed from the coiled protector, the initial observation was that the fiber was severely kinked.The location of the damage is 81cm from the distal tip.Under magnification the fiber optic beneath the cladding has been broken.The blue cladding had a wrinkled appearance but was still intact.Due to the package being opened it could not be definitively determined if the fiber was broken during placement into the protective coil, or during handling of the device when being removed from the coil during preparation for use.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 associated with complaint device lot.The instructions for use (ifu) does contain information regarding this failure mode which states, ¿upon removal from package inspect the product to ensure no damage has occurred.¿ based on the provided information a definitive root cause could not be established.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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6604085
• MDR Text Key: 76527058
• Report Number: 1820334-2017-01075
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00827002252936
• UDI-Public: (01)00827002252936(17)191115(10)7444819
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HLF-S200-HSMA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1