MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV SHIELDED TOTALVIEW ENDOILLUMINATION PROBE INCL ILLUMINATED SCLERAL DEPRESSOR 25G

Catalog Number	3269.SBS05
Medical Device Problem Code	Physical Property Issue (3008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation showed that when the fiber is inserted several times this kind of fracture is not possible.The investigation showed that the outside layer of the fiber is torn apart.This is not a production related error.This is a user error.Assuming worst case during surgery, the shaft tip got broken several times when the surgeon inserting the instrument into the patient's eye.This may cause a severe harm in the eye of the patient.Hence considered reportable.There is no information reasonably suggesting that the patient was harmed.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre (b)(4)).Details of this activity were discussed with cdrh office of compliance (b)(4) during a tele-conference on (b)(4) 2017.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
During operation, the doctor inserted this instrument into a patient's eye several times.And then, the shaft tip part got broken.No further information is available.All information has been disclosed.

• Brand Name: SHIELDED TOTALVIEW ENDOILLUMINATION PROBE INCL ILLUMINATED SCLERAL DEPRESSOR 25G
• Common Device Name: SHIELDED TOTALVIEW ENDOILLUMINATION PROBE INCL ILLUMINATED SCLERAL DEPRESSOR 25G
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7520326
• Report Number: 1222074-2018-00135
• Device Sequence Number: 1164701
• Product Code: MPA
• UDI-Device Identifier: 08717872017433
• UDI-Public: 08717872017433
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/22/2015

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: 3269.SBS05
• Device Lot Number: 2000369609
• 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: 10/22/2015
• Initial Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1