MAUDE Adverse Event Report: ETHICON INC. LAPRA-TY ABSORBABLE X6::SUTURE CLIP; CLIP, IMPLANTABLE

Model Number XC200

Device Problems Break (1069); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a total prostatectomy on (b)(6) 2022 and an implantable suture clip was used.During the procedure, the clip cracked when the clip was about to feed into the jaw.Another device was used to complete the case.There were no adverse consequences to the patient.Upon evaluation of the returned device, one loose clip broken was found.No additional information was provided.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested but unavailable: please provide the applier product code and lot number? please explain how the clips were loading into the applier? please confirm if the jaws of the applier are at 90 degree to the surface of the clip cartridge when loading? was the applier checked for damaged (jaws straight and aligned)? no further information will be provided.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned sample determined that the xc200 reload was received with one loose clip broken and five clips loaded.In addition, the foil was examined and showed multiple wrinkles and small holes on the bottom cavity of the foil package related possibly to excessive manipulation.The product code xc200 contains absorbable clips and as the sample was received open the degradation process had already begun, the time of exposure to the environment could not be determined and no functional test can be performed due to the sample condition.The reload was received with one clip broken and per the condition of the clips received.This condition caused the reported event. it should be noted that all ethicon product is 100% inspected prior to release.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: LAPRA-TY ABSORBABLE X6::SUTURE CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15847543
• MDR Text Key: 307787984
• Report Number: 2210968-2022-09719
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705031206885
• UDI-Public: 10705031206885
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K931492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XC200
• Device Catalogue Number: XC200
• Device Lot Number: RH2AHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1