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.
[24258311]
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
[24258312]
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
[63531569]
Corrections: updated lot# upon product returned - 1236384. Full udi number added. Investigation summary: a reusable probe plus 45 sterile valves were returned for evaluation. Two of the sterile units from each of the two lots returned were used for functional testing along with the returned probe. 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
| Report Number | 2027111-2015-00595 |
| MDR Report Key | 5033569 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-08-26 |
| Date of Report | 2016-12-12 |
| Date Mfgr Received | 2015-08-13 |
| Date Added to Maude | 2015-08-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138233 |
| Manufacturer G1 | APPLIED MEDICAL |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92688 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C7202, 5MMX33CM, EPIX REUSABLE PROBE |
| Generic Name | FHF |
| Product Code | FHF |
| Date Received | 2015-08-26 |
| Returned To Mfg | 2015-09-10 |
| Model Number | C7202 |
| Catalog Number | 101260701 |
| Lot Number | 1235810 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-26 |