MAUDE Adverse Event Report: D.O.R.C INTERNATIONAL EVA TDC VITRECTOMY PACK VGPC INPUT 25G

Model Number	8310.25G02
Medical Device Problem Codes	Obstruction of Flow (2423); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Intraocular Pressure, Delayed, Uncontrolled (1936)
Date of Event	08/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Note: at this time investigation is ongoing.Any new or clarified information will be submitted in a supplemental report.
Event or Problem Description
The equipment was set up, priming ok and during phaco the pressure in the anterior chamber was very low.As the surgeon started the vitrectomy, the eye got very soft.All the tubing was changed with no positive effect.The surgeon changed to gravity flow as the eye was too soft during the surgery.After the machine was shut down and restarted, the surgery was complete.The bottle height went up to 100 cm.It was reported that once the pressure was changed to 90 mmhg the cataract surgery was completed.
Additional Manufacturer Narrative
Note: additional information has been received.The users indicated that the infusion pressure was very low during both the phaco and vitrectomy modes which were also confirmed at the log file review of the eva.On the other hand, the log file review revealed with no setting errors had been performed by the user nor obvious software failures.However, further investigation will consider if a mechanical obstruction of the phaco and vitrecome tips as a potential root cause of the low irrigation flow.A supplemental will be submitted once additional information becomes available.Please note associated mdr 1222074-2017-00007 that has been submitted on the eva system.
Event or Problem Description
During the combined phacoemulsification and pars plana vitrectomy surgery, the surgeon experienced low irrigation pressure and the patient's eye turned to very soft.No patient injury, however surgery was prolonged for about 30 minutes.The facility was communicated with to investigate the circumstances of the event as well as with the surgeon and nurses.The log files received have been reviewed.Please note this incident occurred in (b)(6).
Additional Manufacturer Narrative
In order to investigate the circumstances of the event, dorc has communicated with the involved surgeon and nurses.The users indicated that the infusion pressure was very low during both the phaco and vitrectomy modes, which were also confirmed at the log file review of the eva.On the other hand, the log file review revealed with no setting errors had been performed by the user nor obvious software failures.However, further investigation will consider if a mechanical obstruction of the phaco and vitrecome tips as a potential root cause of low irrigation flow.The suspected pump and the eva tdc pack have been returned to dorc for investigation.Please note associated mdr 1222074-2017-00007 that has been submitted on the eva system.Root cause investigation and analysis: assessment regarding the device involved in the field.Dorc had replaced the pump, the eva at field works well with no more similar complaints after then.From the eva memory logfile review, we conclude that the eva was working as designed.The incorrect infusion aspiration pressure were recorded.However, no software nor setting errors were detected by the eva main device.From the returned pump (eva component) inspection, we conclude that the pump is in a good condition and could not have caused the problem as far as all tests were passed and with no deviations were found.Investigation on potential mechanical obstruction, from the inspection on the returned vgpc pack (8310.25g02), with a cartridge, tubings and a vitrectome cutter included, to check whether existence of mechanical obstruction; we conclude that all returned subject accessories which were used are working with no abnormalities.Others-to identify the potential other root causes, we have also considered possible defects of that, infusion clamp and infusion tubing was properly not well connected, such as blockage, folded or twisted of vgpc and irrigation infusion lines or the clamp was not open, forgot to turn the stopcock handle to 90 degrees anti-clockwise as described in the manual.(only applicable to vgpc vitrectomy procedure, phaco mode is not needed.) the cap of air filter of the drip chamber (gravity infusion) was accidentally closed.The vgpc air filter is not well connected.The cannula could be blocked (only in vitrectomy step), however, the sample was not sent back for investigation.Comment-since both phaco and vitrectomy procedures, as well as both vgpc and gravity infusions experienced low irrigation pressures, so these cannot had happened at all these situations if there was only one root cause contributed to the defect.However, since there was no video nor photographs had been taken for review the process of the event, neither from the users, above assumptions cannot be confirmed.Since there is no evidence indicates software or pump problems, it is most likely the defect of low air pressure was caused by a mechanical obstruction.However, we cannot get convincing evidence either about mechanical obstruction.Besides we did not receive further requested data from the hospital, we cannot continue with the investigation thus the outcome of the investigation will stay inconclusive.

• Brand Name: EVA TDC VITRECTOMY PACK VGPC INPUT 25G
• Common Device Name: VITRECTOMY PACK
• Manufacturer (Section D): D.O.R.C INTERNATIONAL; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 6803726
• Report Number: 1222074-2017-00008
• Device Sequence Number: 16414027
• Product Code: HQE
• UDI-Device Identifier: 08717872021041
• UDI-Public: 08717872021041
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 8310.25G02
• Device Catalogue Number: 8310.25G02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 08/22/2017; 09/28/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 08/23/2017; 10/26/2017
• 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