MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT BLUNT TIP 12X100 SMOOTH; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number 2H12LP

Device Problem Structural Problem (2506)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical device: batch # unk.(b)(4).Attempts are being made to obtain additional information.To date, no additional information has been received.If further details are received at a later date, a supplemental medwatch will be sent: did the patient have prolonged hospitalization? if the patient did have prolonged hospitalization, was this prolonged hospitalization related to the reported issue of broken suture tie post? investigation summary the analysis results found that the 2h12lp device was received with one suture tie post broken.The suture tie post was not returned for analysis.No functional test was performed due the condition of the device.Also, the latches on the outer seal were not broken off and were noted in good condition.No conclusion could be reached as to what may have caused the reported incident.One possible cause for the damage found on the suture tie post may be excessive force applied after device is sutured down.Although there is no direct evidence of use error, the instructions for use do contain the following: "caution: insert the trocar into the incision with the adjustable plug secured against the bottom of the trocar sleeve housing.Slide the adjustable plug down the trocar sleeve and into the incision.Pull and wrap the sutures snugly around the suture tie posts on the adjustable plug.This forces the plug firmly into the incision to help seal it and minimize gas leakage later in the procedure.Position the desired amount of trocar sleeve in the abdominal or thoracic cavity by sliding it up or down accordingly.Once the desired sleeve position has been established, secure the adjustable plug to the sleeve by pushing down the locking cam." it should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a laparoscopic cholecystectomy, the suture post came off when wind off the suture post.The sales rep checked the device, and it was found the latches were broken off, and one of them was missing.Although unlikely, there is a possibility that it was left inside the patient.No additional treatment was required.The patient stays in the hospital.No further information is available.

• Brand Name: OPT BLUNT TIP 12X100 SMOOTH
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo ; *
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 11028363
• MDR Text Key: 222079356
• Report Number: 3005075853-2020-06939
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036014256
• UDI-Public: 10705036014256
• Combination Product (y/n): N
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 2H12LP
• Device Catalogue Number: 2H12LP
• Device Lot Number: U40F0K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Date Manufacturer Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR