* 62001G

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-05-12 for * 62001G manufactured by *.

Event Text Entries

[17639542] The speed reducer which suffered a broken shaft was evaluated by engineering upon receipt. Analysis of mfr specs indicated the application was well within specified operational parameters. Results of examination of the failed assembly were inconclusive. The reducer was forwarded to the mfr for analysis. Their response indicated a low lubricant level, input seal leak, and overload as contributing to failure. As mentioned above, overload was not due to design buy may have resulted from operational abuse (e. G. Driving the c-arm into an obstruction). Review of maintenance recommendations in the svc manual indicates that co's recommended lubrication svc interval of 1 yr exceeds the mfr's recommendation of 2500 hrs, based on an estimated 1 hr/day of actual movement of the c-arm axis in question, by a factor of 6. 8. There is no seal maintenance specified by the mfr. Review of the return history for the reducer (which is used in multiple products) for a period of 2 yrs preceding the incident reveals no other returns. Co concludes that this incident is an isolated failure, due to a faulty reducer assembly rec'd from the mfr, failure to perform periodic maintenance as specified in the svc manual, or operator abuse. No remedial or other corrective action is indicated.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1418957-1997-00003
• MDR Report Key: 92303
• Report Source: 06
• Date Received: 1997-05-12
• Date of Event: 1997-04-08
• Date Mfgr Received: 1997-04-21
• Device Manufacturer Date: 1993-09-01
• Date Added to Maude: 1997-05-23
• 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: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 0
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: *
• Product Code: ITY
• Date Received: 1997-05-12
• Model Number: 62001G
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 91175
• Manufacturer: *
• Manufacturer Address: * * *
• Baseline Brand Name: *
• Baseline Generic Name: *
• Baseline Model No: 62001G
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-05-12