C7202, 5MMX33CM, EPIX REUSABLE PROBE 101260701

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-08-26 for C7202, 5MMX33CM, EPIX REUSABLE PROBE 101260701 manufactured by Applied Medical.

Event Text Entries

[24417533] The incident device anticipated to return. A follow-up report will be provided upon completion of investigation. In accordance to 21 cfr 803. 56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
Patient Sequence No: 1, Text Type: N, H10


[24417534] All laparoscopic cases- "having major issues with leakage with the new upgraded disposable hand piece. It looks like a blood bath after a laparoscopy. Leaking appears to be coming from hand piece but possible it could be coming from probes. Will be returning 4 reusable probes model#c7202, lot#1235810 along with new upgraded hand pieces for evaluation. Ed rudy went into account to observe issue and make sure everything was connect properly. Issue still present with proper connection. " patient status- "as expected. "
Patient Sequence No: 1, Text Type: D, B5


[63496047] Corrections: full udi number added. Investigation summary: a reusable probe was returned for evaluation. Upon investigation, engineering found that the event unit functioned as designed when it was assembled with the sterile valve and tubing. There was no apparent leaking. The root cause of this event is likely due to probe cap design. Applied medical continuously seeks to improve the form, function and ease of use of its products. As part of this continuous process, applied medical has improved the design of the probe cap to minimize the potential for this type of event to occur. In accordance to 21 cfr 803. 56, if additional information is obtained which was not known or was not available when this report was submitted, a supplemental report will be submitted to the fda.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2027111-2015-00594
MDR Report Key5033538
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2015-08-26
Date of Report2016-12-12
Date Mfgr Received2015-08-13
Date Added to Maude2015-08-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street22872 AVENIDA EMPRESA
Manufacturer CityRANCHO SANTA MARGARITA CA 92688
Manufacturer CountryUS
Manufacturer Postal92688
Manufacturer Phone9497138233
Manufacturer G1APPLIED MEDICAL
Manufacturer Street22872 AVENIDA EMPRESA
Manufacturer CityRANCHO SANTA MARGARITA CA 92688
Manufacturer CountryUS
Manufacturer Postal Code92688
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameC7202, 5MMX33CM, EPIX REUSABLE PROBE
Generic NameFHF
Product CodeFHF
Date Received2015-08-26
Returned To Mfg2015-09-10
Model NumberC7202
Catalog Number101260701
Lot Number1235810
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAPPLIED MEDICAL
Manufacturer Address22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688


Patients

Patient NumberTreatmentOutcomeDate
10 2015-08-26

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