UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-10 for UNKNOWN manufactured by Ethicon.

Event Text Entries

[1005] During surgery md was suturing peritoneum with endoscopic curved needle driver. While pushing needle driver through trocar sleeve, the needle came loose from driver. Surgeon was unable to visualize needle through laparascope. X-rays were taken, needle was visualized but surgeon was unable to retreive it through port holes. Patient was transferred to fluro-bed, incision was made, and the needle was removed intact withuse of c-arm. There was no lasting adverse effects on patientdevice 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. Invalid data - whether device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: no. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3816
• MDR Report Key: 3816
• Date Received: 1992-07-10
• Date of Report: 1992-01-06
• Date of Event: 1991-12-18
• Date Facility Aware: 1991-12-18
• Report Date: 1992-01-06
• Date Added to Maude: 1993-05-06
• 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

• Generic Name: SUTURING NEEDLE SURGICAL
• Product Code: HAS
• Date Received: 1992-07-10
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• ID Number: N/A
• Operator: OTHER
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3558
• Manufacturer: ETHICON

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-10