N/A 83000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-09 for N/A 83000 manufactured by 3m.

Event Text Entries

[891] During a surgical procedure, the arthroscopic pump malfunctioned presumably due to a failed senso that maintains a constant pressure, causing the tissue around the operative site to infiltrate with fluid. To avoid potential permanent damage to the tissue, the surgical procedure was stopped. Oter devicesused during the procedure included suction, electrical instruments, video light source, camera, monitor, computer and vcr, anesthesia machine and monitoring equipment. The patient was discharged later that day in satisfactory conditiondevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-jan-92. Service provided by: distributor. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed. Results of evaluation: component failure, telemetry failure, unanticipated adverse reaction - short term, component failure. Conclusion: device failure directly caused event, device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3648
• MDR Report Key: 3648
• Date Received: 1992-07-09
• Date of Report: 1992-03-20
• Date of Event: 1992-03-13
• Date Facility Aware: 1992-03-13
• Report Date: 1992-03-20
• Date Reported to Mfgr: 1992-03-19
• Date Added to Maude: 1993-04-28
• 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
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: N/A
• Generic Name: ARTHROSCOPIC PUMP
• Product Code: FHF
• Date Received: 1992-07-09
• Model Number: 83000
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: 40484
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3394
• Manufacturer: 3M

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-09