MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-09 for B11LT B11LTRR manufactured by Stryker Sustainability Solutions Lakeland.
[59981913]
The device was returned to stryker sustainability solutions for evaluation. Upon visual inspection of the returned device, there was evidence of clinical use. Visual inspection of the cannula housing and sleeve revealed no damage. The broken piece returned with the complaint device was part of the obturator tip wing. A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker. Devices are rejected for any obturator tip damage. The device was unlikely to have been released from stryker with the reported failure mode. The most likely root cause is contact with a hard object or other improper handling during the procedure. 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. Do not use excessive force. The bladeless trocar should not be advanced for additional penetration once complete entry has been made into the operative cavity. Possible injury to the internal structures could result due to continued entry of the obturator. The obturator is designed with the optical feature to minimize the risk of penetrating injury to intra-abdominal and intra-thoracic structures. Observe standard precautionary measures for all obturator insertions. The reported event will continue to be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10
[59981914]
It was reported when the surgeon went to sew the fascia, a piece of the trocar was discovered. The piece was retrieved and matched up to the trocar tip to ensure all pieces were recovered before stitching up the patient. There was no patient injury, medical intervention, and extended procedure time reported was minimal. These are commonly used devices that are readily available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001056128-2016-00147 |
| MDR Report Key | 6089385 |
| Date Received | 2016-11-09 |
| Date of Report | 2016-10-14 |
| Date of Event | 2016-10-13 |
| Date Mfgr Received | 2016-10-14 |
| Device Manufacturer Date | 2016-06-14 |
| Date Added to Maude | 2016-11-09 |
| 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 | 0 |
| Brand Name | NA |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED |
| Product Code | NLM |
| Date Received | 2016-11-09 |
| Returned To Mfg | 2016-10-28 |
| Model Number | B11LT |
| Catalog Number | B11LTRR |
| Lot Number | 4657294 |
| Device Expiration Date | 2019-06-14 |
| 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 | 2016-11-09 |