MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-09-07 for T-MAX SHOULDER POSITIONER * manufactured by Tenet Medical Engineering, Inc..
[706710]
A patient was being positioned in the or for a right shoulder arthroscopy using a t-max shoulder positioner supplied for trial use by a representative from tenet medical engineering company. Prior to elevating the shoulder positioner portion of the table, the stability of the table attachment was checked. When the extension was raised, part of the table collapsed causing the intubated patient to slip. The anesthesia and or team caught the patient as well as supported the table to prevent it from falling. The surgery had to be postponed and the patient was extubated successfully. The patient had minor skin abrasion as a result of the incident. One staff member who helped support the patient and table from falling completely ironically sustained a shoulder injury. Analysis of the event revealed that the clamp on the extension failed when it was raised. Prior to the failure, the proper procedures were followed. This device will not be used for future procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 925771 |
| MDR Report Key | 925771 |
| Date Received | 2007-09-07 |
| Date of Report | 2007-08-23 |
| Date of Event | 2007-06-15 |
| Report Date | 2007-08-23 |
| Date Reported to FDA | 2007-09-07 |
| Date Added to Maude | 2007-10-12 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | T-MAX SHOULDER POSITIONER |
| Generic Name | ATTACHMENT, SHOULDER POSITIONER |
| Product Code | BWN |
| Date Received | 2007-09-07 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 897684 |
| Manufacturer | TENET MEDICAL ENGINEERING, INC. |
| Manufacturer Address | SMITH AND NEPHEW, INC. ENDOSCO 160 DASCOMB ROAD ANDOVER MA 01810 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-09-07 | |
| 2 | 0 | 2007-09-07 |