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

Model Number ER320

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device, lot number and no non-conformances were identified.Attempts are being made to obtain the following information: can you please clarify if the clips that were fired out of the device were scissored (crossed)? or were the jaws of the device itself damaged (crossed)? were there any patient consequences? to date, no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that during a lap chole procedure, it was found that the clips crossed "the press" while they were using the er320 product.The clip is very comfortable where they are used.It is unknown how the procedure was completed.Patient consequence was not reported.

• 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: 9650033
• MDR Text Key: 206124047
• Report Number: 3005075853-2020-00626
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2020

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 Expiration Date: 05/31/2023
• Device Model Number: ER320
• Device Catalogue Number: ER320
• Device Lot Number: R40L3J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 01/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1