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

Catalog Number MIC4036

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Finished goods records of mic4036, pebcqqq0 have been reviewed and show no deviations; all results meet the specified quality requirements.Additional information was requested and the following was obtained: package lot number of the clips? ¿ lot number was included in the complaint.Was the clips difficult to load on the device? ¿ it was difficult to load and with some even impossible to load.Were clips used in the procedure? - yes.Were you able to lock the clip closed on the suture? if yes, after it closed, was the clip.Holding securely fixed on the suture? with most it was not possible to clip and close.What suture type was used? polysorb.What suture size was used? 3-0.When the even occurred, was the suture placed near the hinge of the clip? ¿ the suture was placed normally into the clip.Was the applier checked for damage (jaws straight and aligned)? ¿ yes the applier was checked for damage and it was send to repair/ align ¿ no damage was found.Investigation summary: one mic4036 reload was received with no apparent damaged and with only 3 clips loaded.The cartridge was tested for functionality with test device.Upon functional testing of the device, the instrument loaded, retained and deployed the 3 clips as intended.The clips were form as intended and conforming to our manufacturing requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.The event described could not be confirmed as the clips performed without any difficulties noted.

Event Description

It was reported that the patient underwent gastric bypass on (b)(6) 2019 and suture clip was used.During the procedure, it was not possible to grasp the clips with the forceps and they didn't close.The device was difficult to load and with some even impossible to load.With most of the device it was not possible to clip and close.The suture used with the device was polysorb.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
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9262741
• MDR Text Key: 168802597
• Report Number: 2210968-2019-89331
• 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: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MIC4036
• Device Lot Number: PEBCQQQ0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Date Manufacturer Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1