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

Model Number	G25295
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: other non-healthcare professional: or manager.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a urology procedure, the tip of a cook single-use holmium laser fiber broke off inside of the patient.Additional patient and event information has been requested.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Correction: d9, h3 - device was not returned for investigation.Investigation ¿ evaluation.It was reported that customer was using a cook single-use holmium laser fiber (rpn hlf-s365-hsma, lot# 13224508) when the laser fiber tip was broken inside the patient.Several attempts were conducted to obtain additional information and details regarding the incident but no response was received.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control of the device were 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.The device is inspected visually and functionally for cracks and fractures by manufacturing and quality control and no notable gaps in production or processing controls were noted.Review of laser fiber manufacturing document indicates all laser fiber inspected during manufacturing process to assure no breaks are present along the fiber length and green output from end of fiber creates a well-defined circle.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: instructions for use (t_hsmas_rev2) precautions several different factors affect the life of any fiber, including: improper handling, poor laser beam alignment or focus, continuous lasing with the fiber tip in contact with tissue, never subject fiber optics to sharp bends in handling, use, or storage.Extended lasing at high power, discard any fiberoptic assembly that is cracked or broken or does not meet minimum transmission standards.A review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for the complaint lot records no related nonconformances.A complaint database search for same lot number (13224508) revealed there is no other complaint associated with this lot number.Because there are no non-conformances related to laser fiber breakage issue, it was concluded that adequate inspection activities have been established, there is objective evidence that the dhr was fully executed.There is no evidence of nonconforming product in house or in the field.Based on available evidence, cook has concluded that most probable cause of fiber tip breakage can be related to improper handling of laser fiber and any of the precautions listed in the instruction for use (ifu) such as "improper handling", "continuous lasing with the fiber tip in contact with tissue", "poor laser beam alignment or focus", etc.May contribute to laser fiber tip breakage.The appropriate internal personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 11613865
• Report Number: 1820334-2021-01066
• Device Sequence Number: 14326609
• Product Code: GEX
• UDI-Device Identifier: 00827002252950
• UDI-Public: (01)00827002252950(17)230603(10)13224508
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K133788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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 Expiration Date: 06/03/2023
• Device Model Number: G25295
• Device Catalogue Number: HLF-S365-HSMA
• Device Lot Number: 13224508
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1