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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. SKIN STAPLER, 35W, FIXED HEAD STAPLER, SURGICAL

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MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. SKIN STAPLER, 35W, FIXED HEAD STAPLER, SURGICAL Back to Search Results
Model Number 25-3001CNS
Device Problems Mechanical Problem (1384); Misfire (2532); Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/31/2016
Event Type  Malfunction  
Manufacturer Narrative

An internal complaint call (b)(4) was received indicating a skin stapler finished good (b)(6) was not functioning properly. The end user reported the staples would not come out, and when they did, the staples were not "crimping enough to hold. " the initial reporter stated the sample was available for return. However, the sample has not been returned as of the date of this report. The device is supplied to deroyal by modern medical equipment. Therefore, a supplier corrective action request (scar) has been submitted to modern medical. Internal complaints were reviewed for the period of 2014 to present. Four similar complaints of the stapler jamming or failure to properly function were identified for the reported finished good. The investigation is ongoing at this time. When new and critical information is available, this report will be updated.

 
Event Description

The stapler is not functioning properly. Customer states the staple won't come out, and when the staple does come out, it is not crimping enough to hold.

 
Manufacturer Narrative

Root cause analysis: the stapler is supplied to deroyal by (b)(4). Therefore, a supplier corrective action request (scar) was issued to (b)(4). In its response, (b)(4) indicated it was unable to identify the failure. The sample was returned and evaluated with 27 unused staples. The staples were found to operate normally and according to specification. Corrective action: in its scar response, (b)(4) indicated a corrective action has not been taken. It will continue to monitor the reported issue. Investigation summary: an internal complaint (call (b)(4)) was received indicating a skin stapler (finished good 25-3001cns) was not functioning properly. The end user reported the staples would not come out, and when they did, the staples were not "crimping enough to hold. " the initial reporter stated the sample was available for return. The sample was received and forwarded december 12, 2016, to the supplier for evaluation. The device is supplied to deroyal by (b)(4). Therefore, a supplier corrective action request (scar) has been submitted to (b)(4). An initial response was received october 31, 2016; however, that response was updated december 29, 2016, following evaluation of the returned sample. Deroyal quality personnel has reviewed and accepted these responses. In its initial scar response, (b)(4) stated it conducted a device history record review for product manufactured over a three-month period and found no non-conformities. Internal complaints were reviewed for the period of 2014 to present. (b)(4) similar complaints of the stapler jamming or failure to properly function were identified for the reported finished good. Preventive action: a preventive action has not been taken. The investigation is complete at this time. If new and critical information is received, this report will be updated.

 
Event Description

The stapler is not functioning properly. Customer states the staple won't come out, and when the staple does come out, it is not crimping enough to hold.

 
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Brand NameSKIN STAPLER, 35W, FIXED HEAD
Type of DeviceSTAPLER, SURGICAL
Manufacturer (Section D)
MODERN MEDICAL EQUIPMENT MANUFACTURING LTD.
dong xing industrial area
kang le lu, shan xia district
heng li, dongguan guangdong 52346 6
CH 523466
Manufacturer (Section G)
DEROYAL INDUSTRIES, INC.
1703 highway 33 south
new tazewell TN 37825
Manufacturer Contact
elizabeth reed
200 debusk lane
powell, TN 37825
8653621256
MDR Report Key6027652
MDR Text Key57367809
Report Number1060680-2016-00029
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/13/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number25-3001CNS
Device LOT NumberNOT PROVIDED
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/12/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2016
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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