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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL PARSONNET EPICARDIAL RET; INSTRUMENTS, SURGICAL, CARDIOV
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TELEFLEX MEDICAL PARSONNET EPICARDIAL RET; INSTRUMENTS, SURGICAL, CARDIOV Back to Search Results
Catalog Number 342025
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem Laceration(s) (1946)
Event Date 04/08/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.
 
Event Description
The report states: customer has always ordered the epicardial retractors from teleflex.Surgeons are complaining that the newer ones are two stiff and not safe to use on the heart.A surgeon pierced their finger trying to apply the retractor.Additional information regarding pierced finger of surgeon: to my knowledge this was a minor prick and no treatment was required above the normal washing and disinfecting of the site.To our knowledge the patient had no infectious diseases.
 
Event Description
The report states: customer has always ordered the epicardial retractors from teleflex.Surgeons are complaining that the newer ones are two stiff and not safe to use on the heart.A surgeon pierced their finger trying to apply the retractor.Additional information regarding pierced finger of surgeon: to my knowledge this was a minor prick and no treatment was required above the normal washing and disinfecting of the site.To our knowledge the patient had no infectious diseases.
 
Manufacturer Narrative
Qn#(b)(4).The device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to (b)(4).(b)(4) sample of 342025 was received for evaluation.No visual concerns were noted.A dimensional inspection of the spring rod determined that it was on the high side of the specification @ 1.2mm.The device is within specification.A historical review of this device noted that the spring rod was originally specified as 0.8mm ¿0.2mm this was increased to 1.0mm ¿ 0.2mm in 2014.No other complaints have been received in that time frame.Users familiar with or in possession of pre 2014 devices might notice an increase in spring force.Isolated incident.No other complaints have been received for this product line since the changes were made in 2014.A dimensional inspection of the spring rod determined that it was on the high side of the specification @ 1.2mm.The device is within specification.The device functions as expected.No confirmed complaints were received in this range with the same issue.Sap was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 342050.A historical review of this device noted that the spring rod was originally specified as 0.8mm ¿0.2mm this was increased to 1.0mm ¿ 0.2mm in 2014.No other complaints have been received in that time frame.Users familiar with or in possession of pre 2014 devices might notice an increase in spring force.Isolated incident.No other complaints have been received for this product line since the changes were made in 2014.
 
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Brand Name
PARSONNET EPICARDIAL RET
Type of Device
INSTRUMENTS, SURGICAL, CARDIOV
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key10029333
MDR Text Key190056772
Report Number3011137372-2020-00107
Device Sequence Number1
Product Code DWS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 04/08/2020
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 Catalogue Number342025
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2020
Initial Date Manufacturer Received 04/08/2020
Initial Date FDA Received05/06/2020
Supplement Dates Manufacturer Received06/05/2020
Supplement Dates FDA Received06/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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