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

Model Number	CATCH12
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2019
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 laparoscopic bariatric surgery, in the middle of insertion of the retrieval bag into the trocar to collect the resected stomach, creaking sound was generated.The surgeon felt strong resistance despite of that the catch was able to be inserted into the abdominal cavity and the specimen collection was performed.The bag tip was closed and the trocar sleeve was removed to the outside of body, and an attempt was made to pull the shaft of the catch out of the trocar after specimen collection ,but it could not be pulled.A new trocar was taken out, and the procedure was completed without problem after checking the inside of the abdominal cavity.There was no patient injury.
Additional Manufacturer Narrative
Additional information: d10, g4, h3, h6 h3 evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted that the product was returned used, without the pouch.No visual abnormalities were noticed.The device was retuned stuck inside of a trocar.Functional testing could not be done due to the device being returned stuck inside of a trocar.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• 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: 9459999
• Report Number: 2936999-2019-01020
• Device Sequence Number: 19602445
• Product Code: GCJ
• UDI-Device Identifier: 10884521704053
• UDI-Public: 10884521704053
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2020
• Device Model Number: CATCH12
• Device Catalogue Number: CATCH12
• Device Lot Number: C2101617G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1