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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY PROXIMATE PLUS MD STAPLER 35W; ETHICON STAPLER

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ETHICON ENDO-SURGERY PROXIMATE PLUS MD STAPLER 35W; ETHICON STAPLER Back to Search Results
Device Problems Detachment Of Device Component (1104); Other (for use when an appropriate device code cannot be identified) (2203); Device Operates Differently Than Expected (2913)
Patient Problem Wound Dehiscence (1154)
Event Date 02/02/2017
Event Type  malfunction  
Event Description
Delay in reporting due to unable to locate the affected pt.Back on 02/27/2017, had filed a medwatch: (b)(4) and reported that there had been 3 incidence of staples falling out of pts incision requiring intervention.Was going to complete 3 different med-watches for each pt.The one listed above was completed.One would not locate who the pt was and then the third i could not confirm the pt as the chart did not reflect what was reported.Just found the one pt that we could not locate back in (b)(6).Found that on (b)(6) 2017 am the pt had a total abd.Hysterectomy with bso.No complication listed from surgery report, but the following morning (b)(6) 2017 at 0730, there is documentation that 2 staples were not attached to the skin and laying inside incision flap on left end of incision.These staples were removed, area cleaned and steri strips applied.Noted oozing serosanguinous from the area of incision as well as bruising.During the day the pt had developed complications.Returned to surgery the following day.Was discharged home on (b)(6) 2017.This was reported after surgery so the staples was not available to return and none of the lot or model number were available.Have been in contact with mfr with updated info and waiting on return call now.
 
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Brand Name
PROXIMATE PLUS MD STAPLER 35W
Type of Device
ETHICON STAPLER
Manufacturer (Section D)
ETHICON ENDO-SURGERY
4545 creek road
cincinnati OH 45242
MDR Report Key6541562
MDR Text Key74412604
Report Number6541562
Device Sequence Number1
Product Code GDW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/20/2017
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/20/2017
Distributor Facility Aware Date02/06/2017
Event Location Hospital
Date Report to Manufacturer04/20/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/02/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age34 YR
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