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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROLINE SURGICAL INC. DISPOSABLE 19 MEDIUM/LARGE TITANIUM K2 CLIP CART CLIP IMPLANTABLE

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MICROLINE SURGICAL INC. DISPOSABLE 19 MEDIUM/LARGE TITANIUM K2 CLIP CART CLIP IMPLANTABLE Back to Search Results
Model Number 1112
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/24/2017
Event Type  Malfunction  
Manufacturer Narrative

Product not returned. No investigation can be performed at this time.

 
Event Description

During a surgical cholecystectomy, the surgeon attempted to fire a clips and experienced a mechanical jam. The procedure and anesthesia time was extended for 20 minutes. There was no harm to the patient.

 
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Brand NameDISPOSABLE 19 MEDIUM/LARGE TITANIUM K2 CLIP CART
Type of DeviceCLIP IMPLANTABLE
Manufacturer (Section D)
MICROLINE SURGICAL INC.
50 dunham road
suite 1500
beverly MA 01915
Manufacturer (Section G)
MICROLINE SURGICAL INC.
50 dunham road
suite 1500
beverly MA 01915
Manufacturer Contact
anu gaur
50 dunham road
suite 1500
beverly, MA 01915
9789229810
MDR Report Key7013598
MDR Text Key92643159
Report Number1223422-2017-00134
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeEG
PMA/PMN NumberK013695
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/09/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1112
Device Catalogue Number1112
Device LOT Number00130788
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/27/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/28/2016
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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