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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO CLINCH* II 5MM INSTRUMENT FORCEPS, OBSTETRICAL

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COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO CLINCH* II 5MM INSTRUMENT FORCEPS, OBSTETRICAL Back to Search Results
Model Number 174317
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/30/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
According to the reporter, the device broke after the surgeon closed and opened the device a few times. Udi number is not available. The event occurred in use for patient. The procedure was completed with another device. The surgical time was not extended. The status of the patient: no problem. Additional tissue resection is not required. There was no tissue damage. The incision site was not extended. Nothing fell into the patient's cavity. The product did not lock on tissue and was removed from the tissue without damaging it. No bleeding occurred. Female patient the patient age is not available. The patient weight is not available. The device was not reprocessed/re-sterilized prior to use.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4). Evaluation summary: post market vigilance (pmv) concurrently with engineering led an evaluation of one device opened by the account and one photograph. The visual inspection of the device and photograph noted that the instrument was received broken in pieces. There was evidence of material transfer on both halves of the device. Replication of the observed damage may occur as a result of rough handling. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
 
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Type of DeviceFORCEPS, OBSTETRICAL
Manufacturer (Section D)
COVIDIEN, FORMERLY USSC PUERTO RICO INC
building 911-67
sabanetas industrial park
ponce PR 00731
Manufacturer (Section G)
COVIDIEN, FORMERLY USSC PUERTO RICO INC
building 911-67
sabanetas industrial park
ponce PR 00731
Manufacturer Contact
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key6066242
MDR Text Key58747520
Report Number2647580-2016-00885
Device Sequence Number1
Product Code HAD
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K903205
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number174317
Device Catalogue Number174317
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2017
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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