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	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer name and address- postal code: (b)(6).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, the distal tip of a cook® single-use holmium laser fiber was found broken and disconnected when testing the device with a laser machine.The laser fiber was recognized by the laser machine but was not used during the procedure due to the broken tip.Another laser fiber was opened to complete 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.
Additional Manufacturer Narrative
Summary of event: as reported, the distal tip of a cook® single-use holmium laser fiber was found broken and disconnected when testing the device with a laser machine.The laser fiber was recognized by the laser machine but was not used during the procedure due to the broken tip.Another laser fiber was opened to complete 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 the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.No device was returned for investigation.A document-based investigation evaluation was performed.No related non-conformances were recorded.One other complaint was reported for this lot number describing an unrelated failure mode.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.No gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is included with instructions for use which caution that several different factors affect the life of a laser 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.Based on available information, cook has concluded that a cause for this event could not be determined.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.
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: 12019852
• Report Number: 1820334-2021-01534
• Device Sequence Number: 16995133
• Product Code: GEX
• UDI-Device Identifier: 00827002252936
• UDI-Public: (01)00827002252936(17)240125(10)13713308
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: 01/25/2024
• Device Model Number: G25293
• Device Catalogue Number: HLF-S200-HSMA
• Device Lot Number: 13713308
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1