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

Model Number	K2013151
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the fiber not being obtained for dmta evaluation, this complaint can not be confirmed.All records indicate the device was manufactured and released to dornier specification.It can be confirmed that all holmium fibers are 100% tested for defects and energy transmission prior to release by quality for distribution.Without access to the suspect fibers for evaluation no determination can be made regarding if the units identified performed as intended or if the units exhibit manufacturing defect(s).
Event or Problem Description
Complaint details provided in the initial notification stated, "we received a customer complaint about burning of the new 270 micrometer reusable fibers.They have damaged 3 unused fibers".
Additional Manufacturer Narrative
Due to the fiber not being obtained for dmta evaluation, this complaint can not be confirmed.All records indicate the device was manufactured and released to dornier specification.It can be confirmed that all holmium fibers are 100% tested for defects and energy transmission prior to release by quality for distribution.Without access to the suspect fibers for evaluation no determination can be made regarding if the units identified performed as intended or if the units exhibit manufacturing defect(s).Follow up #1 - 2 december 2019: the rfid tag was verified for each of the four returned units which indicated the devices were manufactured and released to dornier specifications.It can be confirmed that all holmium fibers are 100% tested for defects and energy transmission prior to release by quality for distribution.It is acknowledged the information revealed in the evaluation of the returned units did not align with the information received from the complainant.Three of the four returned units were used for 5-6 cases a piece, confirmed to have emitted 22500j, 36400j, and 42440j respectively.It is not likely with this confirmation that the units displayed any manufacturing defects or batch flaws.The unit which was unable to be verified for use may have been utilized with an non-rfid enabled laser as the proximal end of the unit displayed characteristics of use (scratches), pictures were collected during the review of the units for reference.Green aiming beams were noted upon connection with a dornier testing laser.The green aiming beams would not be visible in the case of fiber sma pin burn.The unit which was unconfirmed for use was noted with a clean aiming beam where as the other 3 units were noted with an uneven aiming beam which may be an indication the unit was not reprocessed by the facility as was confirmed for the other units.The complaint as reported can not be confirmed.New details received did not change or expand the risk or reportability associated with this complaint.
Event or Problem Description
Complaint details provided in the initial notification stated, "we received a customer complaint about burning of the new 270 micrometer reusable fibers.They have damaged 3 unused fibers".

• 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 30144
• MDR Report Key: 9220729
• Report Number: 1037955-2019-00047
• Device Sequence Number: 14124467
• Product Code: GEX
• UDI-Device Identifier: 04049958003158
• UDI-Public: 01040499580031581724060310F2
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/23/2019

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: 06/03/2024
• Device Model Number: K2013151
• Device Lot Number: F2219R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Device Age: 4 MO
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1