MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-21 for C6001, 5MMX33CM PROB/VALV DB, G2, 12/BX 101256901 manufactured by Applied Medical.
[34772281]
(b)(4). No product is being returned for evaluation but lot # is provided. A device history report is to be reviewed by engineering. A follow up report will be sent once the results have been analyzed. 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
[34772282]
Lap general procedure - "the suction part was activated and became stuck down, sucking up bowel and causing damage. " patient status- "fine. "
Patient Sequence No: 1, Text Type: D, B5
[61638807]
Additional information was received. The event unit was not returned for evaluation. In the absence of the subject device, it is difficult to determine the root cause of the event. It is possible that the root cause might be attributed to the design of the hand piece. Applied medical has implemented device enhancements intended to minimize the potential for this type of event to occur. Although the root cause of the event could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary. In accordance with 21 cfr 803. 56, if additional information is obtained which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.
Patient Sequence No: 1, Text Type: N, H10
[61638808]
Additional information received via email from applied medical team member on (b)(6) 2015: the unit will not return. It was contaminated and was disposed of. The procedure was a hemicolectomy. They are unsure what the suction pressure was set to during the operation. No damage was caused to the patient. No surgical intervention required. The bowel did not make it to the handpiece. The bowel was released from the probe by disconnecting the suction tube. They are unsure of the sequence of events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2015-00914 |
| MDR Report Key | 5316948 |
| Date Received | 2015-12-21 |
| Date of Report | 2015-12-08 |
| Date of Event | 2015-12-07 |
| Date Mfgr Received | 2016-11-23 |
| Device Manufacturer Date | 2015-07-01 |
| Date Added to Maude | 2015-12-21 |
| 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 | C6001, 5MMX33CM PROB/VALV DB, G2, 12/BX |
| Generic Name | FHF |
| Product Code | FHF |
| Date Received | 2015-12-21 |
| Model Number | C6001 |
| Catalog Number | 101256901 |
| Lot Number | 1250619 |
| ID Number | 00607915116989 |
| Device Expiration Date | 2017-07-30 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-12-21 |