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

Model Number	G25294
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k #: k133788.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
It was reported that during a stone manipulation procedure, using a holmium laser, three cook® single-use holmium laser fibers were used and the tips of the fibers broke off.The procedure was completed using another laser fiber.Surgery was successfully completed with no adverse effects at this time.The patient did not require any additional procedures due to this occurrence.
Event or Problem Description
No additional information has been received since the last report was submitted on 11dec2019.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation - evaluation: reviews of complaint history, device history record, manufacturing instructions, quality control data, and the instructions for use (ifu) 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.There is no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no non-conformances associated with reported allegation of fiber breakage, it was concluded that adequate inspection activities have been established and there is objective evidence that the dhr was fully executed.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: improper handling.Continuous lasing with the fiber tip in contact with tissue.Never subject fiber optics to sharp bends in handling, use, or storage.Fiber should not be clamped with forceps or other securing instruments as it could result in fiber damage or breakage.Extended lasing at high power, lasing with a contaminated or damage proximal.Poor lasing beam alignment or focus.Cook has concluded that based on the evidence presented, potential causes of fiber breakage can be related to improper handling of laser fibers as three laser fiber breakages occurred during a single procedure.Any of the precautions listed in the ifu could also contribute to this event.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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: 9451723
• Report Number: 1820334-2019-03086
• Device Sequence Number: 2606867
• Product Code: GEX
• UDI-Device Identifier: 00827002252943
• UDI-Public: (01)00827002252943(17)220626(10)9839051
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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: 06/26/2022
• Device Model Number: G25294
• Device Catalogue Number: HLF-S273-HSMA
• Device Lot Number: 9839051
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 12/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LUMENIS POWERSUIT-100W LASER.
• Patient Age: 55 YR
• Patient Weight: 79