MAUDE Adverse Event Report: D.O.R.C INTERNATIONAL BV DISPOSABLE HIGH SPEED TDC CUTTER 23 G / 6000 CPM / DORC CONTINUUM RANGE; OPHTHALMIC SURGICAL INSTRUMENT HANDLE, PNEUMATIC

Model Number	6268.NMD06
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	12/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
During the vitrectomy surgery, the surgeon heard a sudden blasting sound in the vitrectome cutter.Afterwards the cutting did not work, with strong air bubbles came out from the tip of the vitrectome instead.This caused damage to the patient's retina.Injected gas instantly damaged the peripheral retina.Fortunately, the tear was far from macula; in the end, the patient's vision was not obviously impacted.The investigation is in progress and a supplemental will be filed once complete.
Additional Manufacturer Narrative
D.O.R.C.Investigation has shown that the root cause of the problem is the incorrect (swapped) assembly of the connectors on the pressure and aspiration lines.As a result the pressure line was connected to the aspiration port.As the associate system is not provided with 'incorrectly connected tubing' detection, this was not detected, resulting in an unexpected flow of air into the eye.As the assembly of the tubing for the 6268.Nmd06 is outsourced, d.O.R.C.Also requested the company concerned to investigate this issue.It was found that: this lot was built in june 2017; three operators participated in the building and visual inspection of this assembly.One of them was a new operator, who has no longer been working at the company; white connector cannot easily be assembled in the incorrect tubing, unless it is manually forced, which is unlikely to happen with seasoned operators; the possibility of continuously assembling the white connector in the incorrect tubing is unlikely given the difficulties associated with it.As root cause is indicated: root cause attributed to a new operator who erroneously switched the connectors on one assembly and the error going unidentified, as originally suspected.As mentioned in the complaint report of company to which the assembly of the tubing for the (b)(4) is outsourced: 1) awareness training was conducted with clean room operators and the sequence of steps and inspection was reviewed and discussed.It was determined that the right steps are present in the work instruction and that physical restrictions are present to prevent this issue; 2) a capa ((b)(4)) has been initiated to further investigate this.As we did not become aware of similar incidents, this failure is considered a single occurrence.

• Brand Name: DISPOSABLE HIGH SPEED TDC CUTTER 23 G / 6000 CPM / DORC CONTINUUM RANGE
• Common Device Name: OPHTHALMIC SURGICAL INSTRUMENT HANDLE, PNEUMATIC
• Manufacturer (Section D): D.O.R.C INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 7184676
• Report Number: 1222074-2018-00002
• Device Sequence Number: 1250343
• Product Code: HQE
• UDI-Device Identifier: 08717872020792
• UDI-Public: 08717872020792
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 01/17/2018

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 Expiration Date: 07/31/2022
• Device Model Number: 6268.NMD06
• Device Lot Number: 2000388600
• 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: 12/15/2017
• Supplement Date Received by Manufacturer: 01/11/2018; 01/17/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 01/16/2018; 01/30/2018
• 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