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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CELESTICA ELECTRONICS S PTE LTD RELIACATCH; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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CELESTICA ELECTRONICS S PTE LTD RELIACATCH; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number CATCH12
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/11/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during laparoscopic lobectomy, the bag tore when it was time to retrieve the cancerous lung, which led to the cancer nodule being in contact with the parietal wall.The specimen had to be manually retrieved.There was no patient injury.
 
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Brand Name
RELIACATCH
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
CELESTICA ELECTRONICS S PTE LTD
no. 6 serangoon north avenue 5
singapore 55491 0
SG  554910
Manufacturer (Section G)
CELESTICA ELECTRONICS S PTE LTD
no. 6 serangoon north avenue 5
singapore 55491 0
SG   554910
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key9517805
MDR Text Key172701940
Report Number2936999-2019-01053
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier10884521704053
UDI-Public10884521704053
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K163102
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/25/2019
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 Model NumberCATCH12
Device Catalogue NumberCATCH12
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/11/2019
Initial Date FDA Received12/25/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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