MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. SHIELDED TOTALVIEW ENDOILLUMINATION PROBE, INCLUDING ILLUMINATED SCLERAL DEPRESS; OPHTHALMIC FIBREOPTIC-LIGHT INSTRUMENT, SINGLE-USE

Catalog Number 3269.SBS05

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

We were informed that prior to use, foreign material was noticed on the instrument.Therefore, the endoillumination probe was not used.No patient harm occurred.

Manufacturer Narrative

Despite the complaint information indicated that the failure was detected prior to use, visual inspection of the returned product revealed that the probe was in fact used.The tip of the optical fiber appeared to be melted.The observed damage compromised the light output.The melted fiber was most likely caused by an undue build-up of heat as a result of the presence of tissue or blood residue during use.Since the heat may cause the fiber tip to melt when the light source is active, it is recommended that the light source is switched off directly after the instrument is removed from the eye.This failure is not considered manufacturer related.

Event Description

We were informed that prior to use, foreign material was noticed on the instrument.Therefor the product was not used.No patient harm occurred.

• Brand Name: SHIELDED TOTALVIEW ENDOILLUMINATION PROBE, INCLUDING ILLUMINATED SCLERAL DEPRESS
• Type of Device: OPHTHALMIC FIBREOPTIC-LIGHT INSTRUMENT, SINGLE-USE
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuiland, 3214V N; NL 3214VN
• Manufacturer (Section G): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuiland, 3214V N; NL 3214VN
• Manufacturer Contact: danielle sleegers ; scheijdelveweg 2; zuiland, 3214V-N ; NL 3214VN
• MDR Report Key: 15092727
• MDR Text Key: 304702166
• Report Number: 1222074-2022-00053
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3269.SBS05
• Device Lot Number: 2409030
• Is the Reporter a Health Professional?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1