MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2006-04-24 for 2080 IA SURGICAL TABLE 2161200 TC-800 manufactured by Steris Corporation - Montgomery.
[18980310]
Pt was positioned for shoulder scope on operating room table - arm of table broke. Two steel pins broke in half. Pt was not injured.
Patient Sequence No: 1, Text Type: D, B5
[19042736]
No injury to the pt due to the event. (b)(4). Steris does not offer the old style pin because there is normally damage to the taper pin holes in the lever arm assembly and the taper pins will not stay securely in the holes. The customer was told to order and replace the entire back section level arm assembly, pn p055114-001, which comes with the new taper style pins. The customer had gotten the prior pins for repairing the table, from a 3rd party (b)(4). At first they were under the assumption that they had gotten the part from us and were concerned as to why we would still stock a part that has been updated by another. The tech asked them to produce a shipping receipt to confirm the origin of the parts. Evidently they thought that since the parts arrived in a "steris" box that they came from us. The tech also did an investigation and contacted dispatch to ensure that the old pins could not be ordered. They have ordered the back support replacement kit to install in the place of their previous repair. The tech confirmed on 4/18/2006, that the customer reported to him that they had completed the repairs. Add'l info from uf report: report date: 03/23/2006. Brand name: amsco surgical table. Common device name: o. R. Table. Model: 2080mia.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043572-2006-00004 |
| MDR Report Key | 2393226 |
| Report Source | 06,07 |
| Date Received | 2006-04-24 |
| Date of Report | 2006-04-24 |
| Date of Event | 2006-03-21 |
| Date Facility Aware | 2006-03-23 |
| Report Date | 2006-03-23 |
| Date Mfgr Received | 2006-03-29 |
| Device Manufacturer Date | 1998-02-17 |
| Date Added to Maude | 2012-01-03 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROBERT MCCALL |
| Manufacturer Street | 2720 GUNTER PARK DRIVE EAST |
| Manufacturer City | MONTGOMERY AL 36109 |
| Manufacturer Country | US |
| Manufacturer Postal | 36109 |
| Manufacturer Phone | 3342133150 |
| Manufacturer G1 | STERIS CORPORATION |
| Manufacturer Street | 2720 GUNTER PARK DRIVE EAST |
| Manufacturer City | MONTGOMERY AL 36109 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 36109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2080 IA SURGICAL TABLE |
| Generic Name | MANUAL SURGICAL TABLES AND ACCESSORIES |
| Product Code | FSE |
| Date Received | 2006-04-24 |
| Returned To Mfg | 2006-04-07 |
| Model Number | 2161200 |
| Catalog Number | TC-800 |
| Lot Number | NA |
| ID Number | BE56-727-000-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 96 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Address | MONTGOMERY AL 36109 US 36109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-04-24 |