MAUDE Adverse Event Report: ASENSUS SURGICAL, INC. SENHANCE; SENHANCE SURGICAL SYSTEM

Model Number	X0007029
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported by the complainant, during a gynecological procedure, it was observed that the insulation from the monopolar scissors was no longer intact.The instrument emitted sparking and delivered heat to unwanted tissue areas.No patient harm was reported since the event was noticed in time and the procedure was converted to traditional laparoscopy during the last surgical steps to avoid any harm to the patient.The malfunctioned monopolar scissors were requested by asensus surgical to be returned to conduct further investigation.A device history record review has been performed with no anomalous findings.The instrument was retrieved and shipped to asensus surgical inc.For further analysis.The r&d team analyzed the device and confirmed that the insulation was damaged.Also, it was noticed that the open/close action of the jaws did not cause any insulation movement exposing metal parts.A bench test was set up with the scissors on a saline-soaked sponge.Using both instruments, the sustaining team was able to recreate the failure mode seen at university hospital tubingen, only when the insulation was touching the sponge.The results of the test confirmed the instrument damage probably was due to wear and tear of the instrument.According to the results of the tests, the damaged products will be disposed of.The root cause of the emitted sparking is related to the wear and tear of the insulation part of the instrument.However, according to the available information, the instrument was visually inspected before use, but not according to the indications provided by the manufacturer.Per the ifu (um-001-00045), the following is noted regarding instrument use: "inspect instruments for damage before each use, especially the insulation of laparoscopic/endoscopic instruments.This may be done visually under magnification or with a high voltage insulation testing device.Insulation failures may result in burns or other injuries to the patient or operator.Visual inspection alone may not be sufficient to ensure that the insulation is intact." per the communication from the clinical specialist, the instrument was only visually inspected before use without magnification or a high voltage insulation testing device.
Event or Problem Description
The event occurred on 10/11/2023 and reported to asensus on 10/11/2023.The event did not occur within the united states.The event occurred in (b)(6) hospital.As reported by the complainant, during a gynecological procedure, it was observed that the insulation from the monopolar scissors was no longer intact.The instrument emitted sparking and delivered heat to unwanted tissue areas.No patient harm was reported since the event was noticed in time and the procedure was converted to traditional laparoscopy during the last surgical steps to avoid any harm to the patient.*note* - additionally, asensus submitted (b)(4) with file name 3007593944-2023-00014 on (b)(6) 2023.The initial report was submitted within 30 days of awareness of the event but since file name 3007593944-2023-00014 was a duplicate, the submission failed.Asensus attempted to correct this administrative error, however, the submission failed according to the acknowledgements.This initial report, file name is being resubmitted to capture the incident under the correct mfr report number and this submission also includes the investigation details.
Additional Manufacturer Narrative
As reported by the complainant, during a gynecological procedure, it was observed that the insulation from the monopolar scissors was no longer intact.The instrument emitted sparking and delivered heat to unwanted tissue areas.No patient harm was reported since the event was noticed in time and the procedure was converted to traditional laparoscopy during the last surgical steps to avoid any harm to the patient.The malfunctioned monopolar scissors were requested by asensus surgical to be returned to conduct further investigation.A device history record review has been performed with no anomalous findings.The instrument was retrieved and shipped to asensus surgical inc.For further analysis.The r&d team analyzed the device and confirmed that the insulation was damaged.Also, it was noticed that the open/close action of the jaws did not cause any insulation movement exposing metal parts.A bench test was set up with the scissors on a saline-soaked sponge.Using both instruments, the sustaining team was able to recreate the failure mode seen at university hospital tubingen, only when the insulation was touching the sponge.The results of the test confirmed the instrument damage probably was due to wear and tear of the instrument.According to the results of the tests, the damaged products will be disposed of.The root cause of the emitted sparking is related to the wear and tear of the insulation part of the instrument.However, according to the available information, the instrument was visually inspected before use, but not according to the indications provided by the manufacturer.Per the ifu (um-001-00045), the following is noted regarding instrument use: "inspect instruments for damage before each use, especially the insulation of laparoscopic/endoscopic instruments.This may be done visually under magnification or with a high voltage insulation testing device.Insulation failures may result in burns or other injuries to the patient or operator.Visual inspection alone may not be sufficient to ensure that the insulation is intact." per the communication from the clinical specialist, the instrument was only visually inspected before use without magnification or a high voltage insulation testing device.Followup #1: corrected catalog and model number fields that were inadvertently entered into the serial number field.Per fda request, included the full (udi) for this device associated with the event, since asensus previously provided only the gtin and lot numbers.
Event or Problem Description
The event occurred on 10/11/2023 and reported to asensus on 10/11/2023.The event did not occur within the united states.The event occurred in (b)(6), germany.As reported by the complainant, during a gynecological procedure, it was observed that the insulation from the monopolar scissors was no longer intact.The instrument emitted sparking and delivered heat to unwanted tissue areas.No patient harm was reported since the event was noticed in time and the procedure was converted to traditional laparoscopy during the last surgical steps to avoid any harm to the patient.Note- additionally, asensus submitted (b)(4) with file name 3007593944-2023-00014 on 31st october 2023.The initial report was submitted within 30 days of awareness of the event but since file name 3007593944-2023-00014 was a duplicate, the submission failed.Asensus attempted to correct this administrative error, however, the submission failed according to the acknowledgements.This initial report, file name 3007593944-2023-00016, is being resubmitted to capture the incident under the correct mfr report number and this submission also includes the investigation details.

• Brand Name: SENHANCE
• Common Device Name: SENHANCE SURGICAL SYSTEM
• Manufacturer (Section D): ASENSUS SURGICAL, INC.; 1 tw alexander drive; suite 160; durham NC 27703 7035
• Manufacturer (Section G): ASENSUS SURGICAL ITALIA, S.R.L; viale dell'innovazione 3; milan, lombardy 20126 ; IT 20126
• Manufacturer Contact: casey hinckley ; 1 tw alexander drive; suite 160; durham, NC 27703-7035 ; 9197658400
• MDR Report Key: 18240519
• Report Number: 3007593944-2023-00016
• Device Sequence Number: 19659612
• Product Code: NAY
• UDI-Device Identifier: 00815440020187
• UDI-Public: (01)00815440020187(11)210901(10)2141574
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: X0007029
• Device Catalogue Number: X0007029
• Device Lot Number: 2141574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female