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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 5X150 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 5X150 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Model Number 2B5XT
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/29/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event or Problem Description
It was reported that during an unknown procedure, the surgeon lacerated the liver with our trocar.Rep reported this was a little laceration.No patient consequence was reported to the rep.No other information is available at this time.
 
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Brand Name
OPT BLADELESS 5X150 STABILITY
Common Device Name
LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
*  00969
MDR Report Key11733296
Report Number3005075853-2021-02307
Device Sequence Number14280142
Product Code GCJ
UDI-Device Identifier10705036013723
UDI-Public10705036013723
Combination Product (Y/N)N
PMA/510(K) Number
K032676
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number2B5XT
Device Catalogue Number2B5XT
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/29/2021
Initial Report FDA Received Date04/27/2021
Patient Sequence Number1
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