MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV VITRECTOMY TDC KIT EVA 1-STEP 23G

Catalog Number	8268.VIT23
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation showed that there are cracks in the thules.During sterilization (with higher temperature) weakener in the pvc tubing of the vitrectome is released.The weakener reacts with the pc material of the thules of the vitrectome.The incident happened during surgery.The cutter makes bubbles.This may cause a severe tissue damage in the eye of the patient, hence considered reportable.Please note the product report is a kit but isolated to part 8288.Vit23 supplied in the kit.During the retrospective review, and as per the complaint description, assuming worst case during surgery, air bubbles observed at the probe.This may cause injury to the patient.Hence it is reportable.The risk is possbile injury by microbial, viral or prion infection (patient harm) this reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer ((b)(4)).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6) 2017.No information reasonable suggests anyone was harmed.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
Customer claimed our cutter makes bubbles, please find attached the claim.Please check and let us have your reply.Sample is available.

• Brand Name: VITRECTOMY TDC KIT EVA 1-STEP 23G
• Common Device Name: VITRECTOMY TDC KIT EVA 1-STEP 23G
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7541053
• Report Number: 1222074-2018-00151
• Device Sequence Number: 1224364
• Product Code: HQC
• UDI-Device Identifier: 08717872020792
• UDI-Public: 08717872020792
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 11/17/2015

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: Physician
• Device Catalogue Number: 8268.VIT23
• Device Lot Number: 2000370100
• 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: 11/17/2015
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1