MAUDE Adverse Event Report: ETHICON INC. LAPRA TY CLIP; CLIP, IMPLANTABLE

Catalog Number MIC4034

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device mic4034; pkbbchq0 number, and no non-conformances were identified.Investigation summary: it was reported that: clip hold error.The analysis results of the mic4034 reload (h) was received with 2 clips loose.However, the clips were out position inside of the cartridge as if tried to loaded the clip, make the reload nonfunctional.Batch records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Due to the condition of the clips, the reported complaint was an external cause as improper handling.Investigation summary: it was reported that: clip hold error.The analysis results of the mic4034 reload (e) was received with only one clip loaded with no apparent damaged.The cartridge was tested for functionality with test device.Upon functional testing of the device, the instrument loaded, retained and deployed the clip as intended.The clip was form as intended and conforming to our manufacturing requirements.Batch records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.The clip performed without any difficulties noted.Note: events reported via mw 2210968-2020-02505, 2210968-2020-02506, 2210968-2020-02510, 2210968-2020-02511, 2210968-2020-02512.

Event Description

It was reported that the patient underwent an unknown procedure on an unknown date and suture clips were used.During the procedure, the clips did not hold.There were no adverse patient consequences reported.

• Brand Name: LAPRA TY CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt ; GM
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9910305
• MDR Text Key: 189168912
• Report Number: 2210968-2020-02509
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K931492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MIC4034
• Device Lot Number: PKBBCHQ0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1