LASER TIP GRP-6 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-15 for LASER TIP GRP-6 * manufactured by Surgical Laser Technologies.

Event Text Entries

[51370] During laparoscopy laser procedure-ovarian cystectomy, laser tip broke off. Apparently in pt's abdomen. Surgeon looked for it and irrigated cavity thoroughly. Tip not located. Co notified for inquiry about tip. Used grp-6, 10 watts. Laser time 6 minutes total. Coolant co2-laser set at. 2-. 4.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number92273
MDR Report Key92273
Date Received1995-02-15
Date of Report1994-10-12
Date of Event1994-10-06
Date Facility Aware1994-10-06
Report Date1994-10-12
Date Reported to Mfgr1994-10-12
Date Added to Maude1997-05-22
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLASER TIP
Generic NameLASER TIP
Product CodeLLW
Date Received1995-02-15
Model NumberGRP-6
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age11 MO
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key91148
ManufacturerSURGICAL LASER TECHNOLOGIES
Manufacturer Address200 CRESSON BLVD. OAKS PA 19456 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1995-02-15

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