MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*MCA MED SHORT APPLIER; CLIP, IMPLANTABLE

Model Number MSM20

Device Problem Mechanics Altered (2984)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4); batch #: unk.Date of event is (b)(6) 2020.Event day was not reported.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts are being made to retrieve the device.To date, the device has not been returned.If the device, or further details are received at a later date, a supplemental medwatch will be sent.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10848946
• MDR Text Key: 218574978
• Report Number: 3005075853-2020-06050
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002505
• UDI-Public: 10705036002505
• Combination Product (y/n): N
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 10/28/2020

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
• Device Operator: Health Professional
• Device Model Number: MSM20
• Device Catalogue Number: MSM20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1