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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA CRYO PROBE: EXTENDED RETINAL, 2.5 MM; DISPOSABLE CRYOPROBES
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D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA CRYO PROBE: EXTENDED RETINAL, 2.5 MM; DISPOSABLE CRYOPROBES Back to Search Results
Catalog Number 1540.D
Device Problem Gas/Air Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
An investigation of the complaint article has been initiated by d.O.R.C.R&d department.
 
Event Description
Gas leakage noted at the connector point where it attaches onto cryomachine.When pedal is depressed, no leakage can be heard.Once pedal is released before machine expels excess gas, hissing from connector can be heard.Cryo worked fine on patient and completed without any problems.Staff concerned on leaking connector.
 
Manufacturer Narrative
With regards to this complaint, one 2.5 mm extended retinal cryo probe was received for investigation.Visual inspection of the connector of the probe revealed no anomalies.After visual inspection, the cryo probe was submerged in water and tested for leakage at 1030 psi.No signs of leakage were observed.After the leak test, the probe was connected to a cryostar and tested in accordance with the device master record.Again, no signs of leakage were detected and the probe appeared to be functioning properly.Based on the investigation performed, the alleged leakage from the connector could not be attributed to the returned cryo probe.
 
Event Description
Gas leakage noted at the connector point where it attaches onto cryomachine.When pedal is depressed, no leakage can be heard.Once pedal is released before machine expels excess gas, hissing from connector can be heard.Cryo worked fine on patient and completed without any problems.Staff concerned on leaking connector.Video attached.
 
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Brand Name
CRYO PROBE: EXTENDED RETINAL, 2.5 MM
Type of Device
DISPOSABLE CRYOPROBES
Manufacturer (Section D)
D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA
scheijdelveqeg 2
zuiland, 3214 VN
NL  3214 VN
MDR Report Key9097217
MDR Text Key197295401
Report Number1222074-2019-00028
Device Sequence Number1
Product Code HRN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2019
Device Operator No Information
Device Catalogue Number1540.D
Device Lot Number2000403371
Patient Sequence Number1
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