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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT BLUNT TIP 12X100; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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ETHICON ENDO-SURGERY, LLC. OPT BLUNT TIP 12X100; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Catalog Number 2H12LP
Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/23/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: was the locking cam reversed on the device: no; was the seal turned the wrong way: yes.
 
Event Description
It was reported that, during an unknown laparoscopic surgery, air leaked since the valves became reversed.Another device was used to complete the case.There were no adverse consequences for the patient.No device will be returned.
 
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Brand Name
OPT BLUNT TIP 12X100
Type of Device
LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo PR 00969
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC
475 calle c
guaynabo PR 00969
Manufacturer Contact
milton garrett
4545 creek road ml 120a
cincinnati, OH 45242
5133378865
MDR Report Key5831563
MDR Text Key51234590
Report Number3005075853-2016-04273
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 06/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2H12LP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/23/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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