MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-02-07 for REPROCESSED ETHICON TROCAR XCEL BLUNT TIP H12LP manufactured by Ascent Healthcare Solutions.
[808206]
A total of 5 reprocessed trocars broke apart during use. One was from lot number 149680, three were from lot number 149764, and one was from an unknown lot number. The five broken trocars were sent to the manufacturer (reprocessor) for analysis. The reprocessor's analysis indicated that, based on their findings, a change would be made in the disassembly procedure involved in reprocessing this trocar. According to the reprocessor, "this modification will assist in mitigating future occurrences of this nature. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1009819 |
| MDR Report Key | 1009819 |
| Date Received | 2008-02-07 |
| Date of Report | 2008-01-30 |
| Date of Event | 2008-01-21 |
| Report Date | 2008-01-30 |
| Date Reported to FDA | 2008-02-07 |
| Date Added to Maude | 2008-03-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REPROCESSED ETHICON TROCAR |
| Generic Name | TROCAR |
| Product Code | NMK |
| Date Received | 2008-02-07 |
| Returned To Mfg | 2007-12-03 |
| Model Number | XCEL BLUNT TIP |
| Catalog Number | H12LP |
| Lot Number | 149680 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 977338 |
| Manufacturer | ASCENT HEALTHCARE SOLUTIONS |
| Manufacturer Address | 10232 SOUTH 51ST STREET PHOENIX AZ 850445205 US |
| Brand Name | REPROCESSED ETHICON TROCAR |
| Generic Name | TROCAR |
| Product Code | NMK |
| Date Received | 2008-02-07 |
| Returned To Mfg | 2008-12-01 |
| Model Number | H12LP |
| Catalog Number | * |
| Lot Number | 149764 |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 2 |
| Device Event Key | 977339 |
| Manufacturer | ASCENT HEALTHCARE SOLUTIONS |
| Manufacturer Address | 10232 S 51ST STREET PHOENIX AZ 850445205 US |
| Brand Name | REPROCESSED ETHICON TROCAR |
| Generic Name | TROCAR |
| Product Code | NMK |
| Date Received | 2008-02-07 |
| Returned To Mfg | 2008-12-01 |
| Model Number | XCEL BLUNT TIP |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 3 |
| Device Event Key | 977340 |
| Manufacturer | ASCENT HEALTHCARE SOLUTIONS |
| Manufacturer Address | 10232 S 51ST STREET PHOENIX AZ 850445205 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-07 |