MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-08 for LITHOTOMY LEG HOLDER manufactured by Steris Corporation - Montgomery.
[110914087]
The lithotomy leg holder is equipped with a stirrup that supports the patient's leg. The stirrup is secured with a snap hook connector that clips onto a ring. The user facility provided photographs of the lithotomy leg holder subject of the reported event. The photographs were reviewed by steris quality and product engineering personnel as part of the investigation and revealed that the stirrup's clip disengaged from the ring due to a gap large enough for the snap hook connector to pass through. By design, the snap hook assembly is assembled in a manner such that the size of the gap in the ring is not sufficient to allow the snap hook to pass through as was seen in this event. A review of all on-hand snap hook assemblies was completed by steris quality personnel and were found to be assembled per specification. A steris service technician arrived onsite following the event and replaced the user facility's snap hook assembly. While onsite, the technician inspected the facility's other lithotomy leg holder assemblies and ensured no gap was present in the ring. The technician tested the lithotomy leg holder assemblies following his repair, confirmed the equipment was operating to specification and returned the units to service. This event is isolated. No other events of this type have ever been reported before. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[110914088]
The user facility reported that during patient preparation prior to the start of the procedure, the patient's leg began to fall from the table's lithotomy leg holder. User facility staff were able to catch the patient's leg; however, the weight of the leg falling caused the doctor's arm to contact the side of the surgical table resulting in a scratch. No medical treatment was sought or administered for the reported scratch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2018-00043 |
| MDR Report Key | 7584059 |
| Date Received | 2018-06-08 |
| Date of Report | 2018-06-08 |
| Date of Event | 2018-05-11 |
| Date Mfgr Received | 2018-05-11 |
| Date Added to Maude | 2018-06-08 |
| 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. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| Manufacturer G1 | STERIS CORPORATION - MONTGOMERY |
| 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 | 0 |
| Brand Name | LITHOTOMY LEG HOLDER |
| Generic Name | LITHOTOMY LEG HOLDER |
| Product Code | BWN |
| Date Received | 2018-06-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Address | 2720 GUNTER PARK DRIVE EAST MONTGOMERY AL 36109 US 36109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-08 |