MAUDE Adverse Event Report: DORNIER MEDTECH AMERICA, INC. DORNIER HOLMIUM LASER FIBER

Model Number	HLFR0270C
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial report is being filed to remain compliant to regulatory submission requirements.Suspect device expected to be returned by the complainant for evaluation but has not yet been received by (b)(4).A follow-up report will be filed once additional information is obtained.
Event or Problem Description
The complainant reported 4 units of 270 micron fibers which were observed to burn during use.
Additional Manufacturer Narrative
The complaint samples received (b)(6) 2020 were reviewed and the evidence of burning on each of the returned four (4) units was confirmed.The state of the laser last used with this holmium fiber is not confirmed and the cause of the apparent burns could not be confirmed from the sample review.The sterilization method used by the complaint facility is also unconfirmed.Each of the returned units was confirmed to have multiple case usage recorded.It can be confirmed each holmium laser fiber is 100% inspected for both visual and power testing performance defects prior to release for distribution and the rfid scan verifications on the return units confirmed each unit was performing to specification prior to release for distribution.
Event or Problem Description
The complainant reported 4 units of 270 micron fibers which were observed to burn during use.

• Brand Name: DORNIER HOLMIUM LASER FIBER
• Common Device Name: HOLMIUM LASER FIBER
• Manufacturer (Section D): DORNIER MEDTECH AMERICA, INC.; 1155 roberts blvd; suite 100; kennesaw,
• MDR Report Key: 9944701
• Report Number: 1037955-2020-00009
• Device Sequence Number: 11501393
• Product Code: GEX
• UDI-Device Identifier: 00810116020072
• UDI-Public: (01)00810116020072(17)230907(10)F3618R
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K123385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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: 09/07/2023
• Device Model Number: HLFR0270C
• Device Catalogue Number: HLFR0270C
• Device Lot Number: F3618R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Device Age: 19 MO
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1