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

Model Number	CATCH12
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2018
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, during a laparoscopic procedure the retrieval bag didn't fit down the step trocar easily.Lubricant was used to get the instrument down the port.There was 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; SG 554910
• MDR Report Key: 8032661
• Report Number: 2936999-2018-00667
• Device Sequence Number: 16518648
• Product Code: GCJ
• UDI-Device Identifier: 20884521704050
• UDI-Public: 20884521704050
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K163102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2018

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 Model Number: CATCH12
• Device Catalogue Number: CATCH12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1