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

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.

• 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 Key: 9517805
• MDR Text Key: 172701940
• Report Number: 2936999-2019-01053
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521704053
• UDI-Public: 10884521704053
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K163102
• Number of Events Reported: 1
• 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 Number: CATCH12
• Device Catalogue Number: CATCH12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1