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

Model Number	G25292
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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, prior to an unknown procedure, a burn was found near the connection port of a cook® single-use holmium laser fiber when testing the device.The device was separated at the burn mark.Another same type device was used to complete the procedure.No adverse effects were reported due to this occurrence.
Event or Problem Description
No new patient or event information since the last report was submitted.
Additional Manufacturer Narrative
Event summary: as reported, prior to an unknown procedure, a burn was found near the connection port of a cook® single-use holmium laser fiber when testing the device.The device was separated at the burn mark.Another same type device was used to complete the procedure.No adverse effects were reported due to this occurrence.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, and quality control data.Device separated and returned in two segment.Handle segment measured approx.132cm and distal segment measured as 22.8cm.Burning and melting appearance noticed at the separation point.Close examination of separation point confirmed several kink and smash signs along the distal segment of fiber.No damage observed on laser fiber red connector.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.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.¿ never subject fiber optics to sharp bends in handling, use, or storage.¿ discard any fiberoptic assembly that is cracked or broken or does not meet minimum transmission standards.Instruction for use: 7.Open any laser aperture cover or door and insert the proximal connector into the laser system; screw on finger-tight based on available evidence, cook has concluded that most probable cause of fiber breakage may be related to improper handling of laser fiber and any of the precautions listed in the ifu such as "improper handling", "never subject fiber optics to sharp bends in handling, use, or storage" and etc.May contribute to laser fiber breakage.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: 12040140
• Report Number: 1820334-2021-01575
• Device Sequence Number: 14542759
• Product Code: GEX
• UDI-Device Identifier: 00827002252929
• UDI-Public: (01)00827002252929(17)221226(10)10233965
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/31/2021

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: 12/26/2022
• Device Model Number: G25292
• Device Catalogue Number: HLF-S150-HSMA
• Device Lot Number: 10233965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1