MAUDE Adverse Event Report: D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV ILLUMINATED STEPPED LASER PROBE, CURVED WITH TAPERED TIP FOR USE IN COMBINATION

Catalog Number	7510.ALC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since this incident occurred during the surgery the detachment of the parts from the tapered joint can cause serious injury to the patient.Therefore this complaint is concluded as reportable.This laser probe has capillary that is broken, we can not investigate the product.(b)(4).All available information has been provided.This complaint has now been closed.
Event or Problem Description
A report has been received from (b)(6).We received a complaint where the parts came off from the tapered joint.We would appreciate it if you could investigate.It was reported that the tip was broken.There is no further information.

• Brand Name: ILLUMINATED STEPPED LASER PROBE, CURVED WITH TAPERED TIP FOR USE IN COMBINATION
• Common Device Name: ILLUMINATED STEPPED LASER PROBE, CURVED WITH TAPERED TIP
• Manufacturer (Section D): D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV; scheijdelveweg 2; zuidland, netherlands 3214 VN; NL 3214 VN
• MDR Report Key: 7245315
• Report Number: 1222074-2018-00017
• Device Sequence Number: 1174184
• Product Code: HQF
• UDI-Device Identifier: 08717872016122
• UDI-Public: 08717872016122
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 08/13/2014

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: 7510.ALC
• Device Lot Number: 2000362545
• 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: 08/13/2014
• Initial Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1