N/A 3797

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-09-22 for N/A 3797 manufactured by Davol.

Event Text Entries

[15711679] During laporoscopic cholecystectomy the davol suction irrigator, attached to chemtron flo regular and abbott irrigation fluid bags and had been working properly, ceased to function properly. Saline was not coming out of the port. Surgical team noted that air/nitrogen was coming the port. The alarm for the insufflator went off at this time. The crna noted that abdominal pressure reading at 60 instead of 15. Abdomen immediately desufflated with no adverse clinical effectsdevice labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: performance tests performed. Results of evaluation: component failure. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1410
• MDR Report Key: 1410
• Date Received: 1992-09-22
• Date of Report: 1992-09-10
• Date of Event: 1992-08-06
• Date Facility Aware: 1992-08-06
• Report Date: 1992-09-10
• Date Reported to FDA: 1992-09-10
• Date Reported to Mfgr: 1992-08-06
• Date Added to Maude: 1992-09-29
• 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: ENDOSCOPIC IRRIGATION SET
• Product Code: GBQ
• Date Received: 1992-09-22
• Model Number: 3797
• Catalog Number: N/A
• Lot Number: 21BC4L22
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-JUL-92
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1353
• Manufacturer: DAVOL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-09-22