L-HOOK TIP

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 L-HOOK TIP manufactured by Davol.

Event Text Entries

[18444493] On 5/13/92, during a laparascopic cholescystectomy, the l-hook tip device was laid on the surgical drapes covering the patient between use of the l-hook tip and the endo-flo suction/irrigation probe. At the end of the operative procedure, a black spot was noticed on the drape covering the patient's mouth. Upon removal of the drapes, the patient was noted to have a second degree burn on the upper lip. The patient is being followed as an outpatient by her surgeon and a plastic surgeon. The operating room staff now uses a mayo stand over the patient to hold such devices where no holster or caddy is provided for the device. The device was on trail use in our operating room at the time of the occurrence. Invalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory condition. 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. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4059
• MDR Report Key: 4059
• Date Received: 1992-07-09
• Date of Report: 1992-06-02
• Date of Event: 1992-05-13
• Date Facility Aware: 1992-05-13
• Report Date: 1992-06-02
• Date Reported to Mfgr: 1992-05-13
• Date Added to Maude: 1993-05-13
• 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: L-HOOK TIP
• Product Code: KCH
• Date Received: 1992-07-09
• ID Number: CODE #43310 L-TIP
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3792
• Manufacturer: DAVOL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-09