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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 5X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

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ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 5X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Model Number 2B5LT
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/20/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
It was reported that during a laparoscopic cholecystectomy, the device "broke about one inch down." the trocar sleeve was broken almost in two pieces, if not for the inner trocar.No pieces were lost from the trocar.A second trocar was used to complete the case.There were no patient consequences.
 
Manufacturer Narrative
(b)(4).Date sent: 7/20/2020.Investigation summary: the analysis results found that the 2b5lt device was returned with the obturator cannula and sleeve damaged.Due to the condition of the device, no functional testing could be performed to evaluate the reported incident.It is possible that the damage was due to an improper handling of the device.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
 
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Brand Name
OPT BLADELESS 5X100 STABILITY
Type of Device
LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
MDR Report Key10182482
MDR Text Key196466097
Report Number3005075853-2020-03155
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier10705036013709
UDI-Public10705036013709
Combination Product (y/n)N
PMA/PMN Number
K032676
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 05/29/2020
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
Device Operator Health Professional
Device Model Number2B5LT
Device Catalogue Number2B5LT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2020
Initial Date Manufacturer Received 05/29/2020
Initial Date FDA Received06/22/2020
Supplement Dates Manufacturer Received06/26/2020
Supplement Dates FDA Received07/20/2020
Patient Sequence Number1
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