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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH + LOMB DISECT-PK CRABTREE 2 1/2MM FLT; HANDHELD SURGICAL INSTRUMENT
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BAUSCH + LOMB DISECT-PK CRABTREE 2 1/2MM FLT; HANDHELD SURGICAL INSTRUMENT Back to Search Results
Model Number N1705 83J
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2017
Event Type  malfunction  
Manufacturer Narrative
The instrument was visually inspected under a microscope.There is no evidence of material defect or manufacturing error.The instrument is bent, nicked, and broken.The instrument was manufactured prior to 2009, the instrument is stamped, laser etching was introduced in 2009.The instrument has been well used, and appears to have been abused.Cannot determine why tip broke.
 
Event Description
The user facility reported during surgery the tip of the instrument broke off in the patient's ear.The doctor was able to remove the piece and continue with the surgery with no issue.
 
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Brand Name
DISECT-PK CRABTREE 2 1/2MM FLT
Type of Device
HANDHELD SURGICAL INSTRUMENT
Manufacturer (Section D)
BAUSCH + LOMB
rochester NY 14609
Manufacturer Contact
juli moore
3365 tree court industrial blv
st. louis, MO 63122
636226-322
MDR Report Key6710972
MDR Text Key79958473
Report Number0001920664-2017-00246
Device Sequence Number0
Product Code KAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Health Professional
Type of Report Initial
Report Date 06/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2017
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberN1705 83J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/21/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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