MAUDE Adverse Event Report: LINA MEDICAL APS LINA XCISE¿, LAPAROSCOPIC MORCELLATOR; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Model Number	MOR-1515-6
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	09/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Malfunctioning equipment: lina xcise (no specifics on the 'malfunction' from reporter).No harm to the patient.An espiner bag was placed through the umbilical trocar for morcellation within a pseudopneumoperitoneum.The specimen placed within the bag and the bag secured through the umbilical incision.The pseudopneumoperitoneum was established within the bag and a 5 mm trocar was placed into the bag from the lateral trocar site.The balloon was inflated and secured this trocar in place.The morcellator was placed at the umbilical trocar site within the espiner bag.The uterus was morcellated and removed from the pelvis.The bag was then removed.Pneumoperitoneum was reestablished.The patient's pelvis was inspected and hemostasis was confirmed.No complications.

• Brand Name: LINA XCISE¿, LAPAROSCOPIC MORCELLATOR
• Common Device Name: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): LINA MEDICAL APS; emergo global representation llc; 2500 bee cave road/bldg 1, ste 300; austin TX 78746
• MDR Report Key: 8107708
• Report Number: 8107708
• Device Sequence Number: 19311217
• Product Code: HET
• UDI-Device Identifier: 05708265004706
• UDI-Public: (01)05708265004706(17)200905(11)170911(10)1738006
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2018
• Report Date (Section F): 11/06/2018

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 Model Number: MOR-1515-6
• Device Catalogue Number: MOR-1515-6
• Device Lot Number: 1738006
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 80
• Date Report Sent to FDA: 11/06/2018