MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-12 for CB12LT CB12LTRR manufactured by Stryker Sustainability Solutions Lakeland.
[90311021]
The device was returned to stryker sustainability solutions for evaluation. Visual inspection showed the device was returned in two pieces with the cannula seal separated from the cannula base and shaft assembly. Two pieces of seal material were also included. Both seal pieces are part of the ring seal which has been separated from the ring seal assembly. All parts showed signs of clinical use. A review of the dhr supports that the device was unlikely to have been released from stryker with the reported failure mode. The most likely root cause is damage during insertion or withdrawal of instruments due to excessive force or other handling methods. The instructions for use (ifu) state: - become familiar with specific model of trocar and cannula prior to employing it in a surgical procedure to avoid damage to patient, to operator or to instrument. - careful handling of instruments is necessary to avoid damage or breakage. - inspect the instruments for any damage. Do not use the instrument if any damage is noted. Return the instrument and packaging to stryker sustainability solutions if it is not in acceptable condition for surgery. - care should be taken when introducing or removing instruments through the cannula sleeve in order to prevent accidental tearing of the seal. The reported event will continue to be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10
[90311022]
It was reported the washer fell off of the trocar during procedure. The washer did not fall into the patient. The piece was easily retrieved. The device was replaced with another trocar to complete the procedure. There was no patient injury, medical intervention, or extended procedure time reported. These are commonly used devices that are readily available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001056128-2017-00126 |
| MDR Report Key | 6946503 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-10-12 |
| Date of Report | 2017-10-12 |
| Date of Event | 2017-09-14 |
| Date Mfgr Received | 2017-09-15 |
| Device Manufacturer Date | 2017-01-26 |
| Date Added to Maude | 2017-10-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JODIE RUECKERT |
| Manufacturer Street | 1810 W. DRAKE DRIVE |
| Manufacturer City | TEMPE AZ 85283 |
| Manufacturer Country | US |
| Manufacturer Postal | 85283 |
| Manufacturer Phone | 8888883433 |
| Manufacturer G1 | STRYKER SUSTAINABILITY SOLUTIONS LAKELAND |
| Manufacturer Street | 5307 GREAT OAK DRIVE |
| Manufacturer City | LAKELAND FL 33815 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33815 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED |
| Product Code | NLM |
| Date Received | 2017-10-12 |
| Returned To Mfg | 2017-09-21 |
| Model Number | CB12LT |
| Catalog Number | CB12LTRR |
| Lot Number | 5748188 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS LAKELAND |
| Manufacturer Address | 5307 GREAT OAK DRIVE LAKELAND FL 33815 US 33815 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-12 |