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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE ILS CIRCULAR STAPLER; STAPLE, IMPLANTABLE
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ETHICON ENDO-SURGERY, LLC. PROXIMATE ILS CIRCULAR STAPLER; STAPLE, IMPLANTABLE Back to Search Results
Catalog Number ME
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/17/2015
Event Type  malfunction  
Event Description
It was reported that during an unknown procedure, the device was defective.Further information is waiting.Unknown how case was completed.There were no adverse consequences for the patient.One device was discarded.
 
Event Description
It was reported that during an unknown procedure, the device was defective.Further information is waiting.Unknown how case was completed.There were no adverse consequences for the patient.One device was discarded.
 
Manufacturer Narrative
(b)(4).Information is unavailable; device was not returned for evaluation.Additional information was requested and the following was obtained: defective device.Stapling on one side only.Another device with the same reference was used to complete the surgery.No consequences to the patient.Because of this event the surgery was lengthened of 30 minutes.The following information was requested, but unavailable: what type of procedure was the device being used in? what was the procedure date? please provide specific details about how the device was defective.How was the case completed?.
 
Manufacturer Narrative
(b)(4).Information is unavailable; device was not returned for evaluation.Additional information was requested and the following was obtained: defective device.Stapling on one side only.Another device with the same reference was used to complete the surgery.No consequences to the patient.Because of this event the surgery was lengthened of 30 minutes.The following information was requested, but unavailable: what type of procedure was the device being used in? what was the procedure date? please provide specific details about how the device was defective.How was the case completed? original medwatch sent (b)(4) 2015 errored out as duplicate report.
 
Manufacturer Narrative
(b)(4).Additional information: the analysis results found that the cdh29a device arrived in good visual condition.The breakaway washer was present and cut and there were no staples present, indicating that the device achieved a full firing stroke.The device was reloaded with staples, a new washer was placed on the device and it was tested for functionality.It fired and formed all the staples as well as completely cut the test media and the breakaway washer without incident.The staple line was complete and the staples were noted to have the proper b-formed shape.No incident related to the reported event was observed during the batch record review.
 
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Brand Name
PROXIMATE ILS CIRCULAR STAPLER
Type of Device
STAPLE, IMPLANTABLE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo PR 0096 9
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC
475 calle c
guaynabo PR 0096 9
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key4746355
MDR Text Key5779851
Report Number3005075853-2015-02814
Device Sequence Number1
Product Code GDW
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K983536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 04/22/2015
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 Expiration Date01/02/2020
Device Catalogue NumberME
Device Lot NumberM4H564
Was Device Available for Evaluation? No
Date Returned to Manufacturer06/05/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/21/2015
Initial Date FDA Received05/04/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received06/09/2015
05/11/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/05/2015
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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