MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-12-14 for CNO12, GELPOINT PATH 9CM CNO11 101351501 manufactured by Applied Medical Resources.
[62380612]
The incident device is 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
[62380613]
Tamis - "transparent instrument protector fell into rectal space during procedure. Instruments used was 10mm 30dg, attraumatic grasper and minopolar diathermy needle electrode. Both angled tem instruments. We discussed the happening after surgery where we concluded that the needle electrode may be the cause of incident. The device is taken care of at the department for pickup. No life threatening situation occured and the instrument protector was easy detected and removed from space. " patient status - "no life threatening situation occured"
Patient Sequence No: 1, Text Type: D, B5
[67368777]
Investigation summary: the event unit was returned for evaluation along with a dislodged instrument shield, an inner component of one of the trocars. Upon investigation, engineering observed scratch marks on the instrument shield, indicating that it had come into contact with an instrument. The root cause of the damage to the instrument shield is contact with an angled instrument. Applied medical's instructions for use (ifu) states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers. All instruments should be centered axially when inserted through the seal to prevent tearing. " applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary. 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, then a supplemental report will be submitted to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2016-00885 |
| MDR Report Key | 6174386 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-12-14 |
| Date of Report | 2017-12-05 |
| Date of Event | 2016-11-10 |
| Date Mfgr Received | 2016-11-15 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2016-12-14 |
| 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 Contact | WENDY KOBAYASHI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CNO12, GELPOINT PATH 9CM |
| Generic Name | FER |
| Product Code | FER |
| Date Received | 2016-12-14 |
| Returned To Mfg | 2017-01-23 |
| Model Number | CNO11 |
| Catalog Number | 101351501 |
| Lot Number | 1235809 |
| Device Expiration Date | 2017-11-30 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 10 | 2016-12-14 |