MAUDE Adverse Event Report: LINA MEDICAL APS LINA POWER MORCELLATOR; LINA MORCELLATOR

Model Number	MOR-1515-6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complained product was not returned so the full investigation could not be performed.However dhr documentation has been reviewed and no non-conformance's were identified during manufacturing process.On stock lot number 1821015 is not available so investigation could not be performed.No further actions required.
Event or Problem Description
"allegedly, the morcellator malfunctioned in the middle of the case.The surgery fellow tried to turn off the morcellator, but was unable to stop the spin of the blade.She eventually got it to stop, and the patient was unharmed, but the fellow was uncomfortable with using it again".
Additional Manufacturer Narrative
All in all dhr documentation has been reviewed and no non-conformances were identified during manufacturing process.Returned device has been sent as used, the signs of usage are visible on the handle and the tube.Furthermore the silicone disc assembled in the back of the morcellator was damaged probably by using to much force and another tool.Moreover we have observed that the product has probably been washed thoroughly.After unscrewing, on the engine and pcb plate clear traces of dampness or wetness is visible.Nevertheless, the cable connections and soldering were checked and everything was correct.The trigger has been mounted correctly.Also the battery power was checked and we saw that the battery had enough power to start.To be sure we used another battery and connected directly to the engine.The engine worked correctly.We also tested relays using a new battery.They worked correctly as well.It is very difficult to give a clear reason why the device continuous activated.Inside the xcise there was severe trace of moisture and fluid from the cleaning performed by the hospital prior to returning the device to us.This made it impossible to conduct a thorough investigation and give clear rootcause.Based on above no corrective actions required.This report is treated like final report.
Event or Problem Description
"allegedly, the morcellator malfunctioned in the middle of the case.The surgery fellow tried to turn off the morcellator, but was unable to stop the spin of the blade.She eventually got it to stop, and the patient was unharmed, but the fellow was uncomfortable with using it again.".
Additional Manufacturer Narrative
Product returned to lina medical (b)(4), investigation was performed, but further evaluation is required.Based on that the final report will be send as soon as evaluation process is finish.
Event or Problem Description
"allegedly, the morcellator malfunctioned in the middle of the case.The surgery fellow tried to turn off the morcellator, but was unable to stop the spin of the blade.She eventually got it to stop, and the patient was unharmed, but the fellow was uncomfortable with using it again.".
Additional Manufacturer Narrative
Lina medical still waiting for the product back.
Event or Problem Description
"allegedly, the morcellator malfunctioned in the middle of the case.The surgery fellow tried to turn off the morcellator, but was unable to stop the spin of the blade.She eventually got it to stop, and the patient was unharmed, but the fellow was uncomfortable with using it again.".

• Brand Name: LINA POWER MORCELLATOR
• Common Device Name: LINA MORCELLATOR
• Manufacturer (Section D): LINA MEDICAL APS; formervangen 5; glostrup, DK260 0; DA DK2600
• MDR Report Key: 8738374
• Report Number: 3007699067-2019-00003
• Device Sequence Number: 2371909
• Product Code: HET
• UDI-Device Identifier: 05708265004706
• UDI-Public: (01)05708265004706(17)210516(11)180522(10)1821015
• Combination Product (Y/N): N
• PMA/510(K) Number: K101458
• 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,Followup,Followup
• Report Date (Section B): 12/13/2019

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: No Information
• Device Expiration Date: 05/16/2021
• Device Model Number: MOR-1515-6
• Device Catalogue Number: MOR-1515-6
• Device Lot Number: 1821015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 06/11/2019; 06/11/2019; 06/11/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 08/13/2019; 12/14/2019; 12/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other