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

Model Number	G25293
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 ureteroscopy, a cook® single-use holmium laser fiber was separated at the distal tip when connected to a laser machine.Another laser fiber was used to continue the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No new patient or procedure information to report.
Additional Manufacturer Narrative
Summary of event: as reported, during a ureteroscopy, a cook® single-use holmium laser fiber was separated at the distal tip when connected to a laser machine.Another laser fiber was used to continue the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during investigation.A visual inspection of the complaint device was also conducted.The complainant returned one open package containing a cook® single-use holmium laser fiber for investigation.The device was separated and returned in two segments, and the laser fiber was broken at the connector.No damage was observed at the clear tip of the fiber.The tip was protruded 6mm, which is within specification.Close examination of the separation point confirmed charring and melting signs, which indicates laser energy was transmitted when the breakage occurred.A document-based investigation evaluation was also performed.A review of device history record (dhr) for the same lot indicates there is no non-conformance associated with this lot.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.A search of complaint history showed no other complaint associated with this lot number.A review of relevant manufacturing documents was conducted.The device is inspected visually and functionally for cracks and fractures by manufacturing and quality control.No notable gaps in production or processing controls were noted.The device is included with instructions for use which caution that several different factors affect the life of a laser fiber, including: "¿ improper handling.¿ 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." based on available evidence.Cook has concluded that most probable cause of fiber breakage can be related to improper handling of laser fiber.Any of the precautions listed in the ifu such as "improper handling", "never subject fiber optics to sharp bends in handling, use, or storage", etc.May contribute to laser fiber breakage.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.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.

• 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: 12032424
• Report Number: 1820334-2021-01566
• Device Sequence Number: 17059746
• Product Code: GEX
• UDI-Device Identifier: 00827002252936
• UDI-Public: (01)00827002252936(17)230504(10)13171386
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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: 05/04/2023
• Device Model Number: G25293
• Device Catalogue Number: HLF-S200-HSMA
• Device Lot Number: 13171386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1