MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-03 for 2B5LT 2B5LTRR manufactured by Stryker Sustainability Solutions Lakeland.
[81852827]
The device was returned to stryker sustainability solutions for evaluation. Visual inspection of the returned device shows evidence of clinical use. The device was returned with the cannula housing block but no obturator housing or optiview shaft. The cannula shaft was broken. Approximately 3 inches of shaft were broken off and 1 inch remained attached to the housing. Further inspection of the cannula shaft revealed damage to the end near the tip. A review of the dhr could not be performed as the lot number was not reported. Devices are rejected for any cannula shaft damage. The most likely root causes are contact with a hard object, excessive force applied to the device, or shipping and/or handling damage subsequent to distribution from stryker. The instructions for use (ifu) state: - minimally invasive procedures should be performed only by persons having adequate training and familiarity with minimally invasive techniques. Consult medical literature relative to techniques, complications, and hazards prior to performance of any minimally invasive procedure. - do not use excessive force. - using sterile technique, remove the instrument from the package. To avoid damage, do not flip the instrument into the sterile field. The reported event will continue to be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10
[81852828]
It was reported the trocar broke in the abdomen of the patient. All pieces were removed from the patient in two minutes through the other trocar with a laparoscopic grasper. There was no patient injury or medical intervention reported. These are commonly used devices that are readily available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001056128-2017-00100 |
| MDR Report Key | 6766011 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-03 |
| Date of Report | 2017-08-03 |
| Date of Event | 2017-06-30 |
| Date Mfgr Received | 2017-07-05 |
| Date Added to Maude | 2017-08-03 |
| 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. MOIRA BARTON VARTY |
| 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 | 2017-08-03 |
| Returned To Mfg | 2017-07-31 |
| Model Number | 2B5LT |
| Catalog Number | 2B5LTRR |
| Lot Number | UNKNOWN |
| 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 | 2017-08-03 |