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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Event is still under investigation at this time.
Event or Problem Description
A cystoscopy, rhp, left pyeloscopy laser stones and 1/0 stent procedure was being conducted on the (b)(6) male patient with recurring left renal stones.During the procedure, the surgeon noticed that the laser was not working.The laser was taken out of the scope and fiber outside and it was noticed that the laser fiber had snapped.The user had to remove the broken piece through the basket from the kidney.(it was noticed that the uteroscope did damage) the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this report indicate the information is unknown, unchanged or unavailable.Manufacturer report # - the is a resubmission of a follow up already sent, due to a previously invalid manufacturer report number (b)(4).Investigation - evaluation: a review of the device history record, documentation, specifications, and quality control was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Per the risk assessment no further action is required.
Event or Problem Description
No new event description information to report at this time.

• 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: 6089909
• Report Number: 1820334-2016-01275
• Device Sequence Number: 16391136
• Product Code: GEX
• UDI-Device Identifier: 00827002485266
• UDI-Public: (01)00827002485266(17)190205(10)6715479
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K073496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HLF-S273-SMA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2016
• Supplement Date Received by Manufacturer: 02/28/2017
• Initial Report FDA Received Date: 11/09/2016
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR