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

Model Number	CATCH10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, at completion of robotic lobectomy, specimen (lobe) was placed in bag and during removal of bag and specimen from the chest, the bag tore.No patient injury.

• Brand Name: RELIACATCH
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CELESTICA ELECTRONICS S PTE LTD; no. 6 serangoon north avenue 5; singapore 55491 0; SN 554910
• MDR Report Key: 11746762
• Report Number: 2936999-2021-00387
• Device Sequence Number: 11866601
• Product Code: GCJ
• UDI-Device Identifier: 10884521704046
• UDI-Public: 10884521704046
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K163102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2023
• Device Model Number: CATCH10
• Device Catalogue Number: CATCH10
• Device Lot Number: C1091320A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1