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

Catalog Number 2H12LP

Device Problem Defective Component (2292)

Patient Problem Perforation (2001)

Event Date 10/30/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 11/22/2023.D4: batch # unk.Additional information was requested and the following was obtained: "the surgeon's comment: the damage on the intestinal duct occurred and the operation converted to open procedure, and additional suture was performed on the intestinal duct.There is a possibility that the issue occurred due to the intraperitoneal search operation for the damaged area.The surgeon's comment: so far, the patient is stable, but still need to follow up for a week." attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: "what is the surgeons experience with this device? what is the patients bmi? what is patients current status? what action was being performed when the device broke? what was the anatomical position of this specific port? was there excessive torquing of the instrument at the time of the breakage? what instruments were passed through the trocar? has there been any re-operations/attempts to look for the pieces left in the patient? does the account use reprocessed trocars or does the account reprocess the trocars in house at the account?" attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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, or its employees that the report constitutes an admission that the product, ethicon, 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.

Event Description

It was reported that during a thoracoscopic gastric tube construction, the trocar came off and the locking lever and broken fixed part was found outside the patient.There is a gap on the sled for to lock, but the surgeon thought that gap was made because the device was broken, so the additional wound was made to find the broken piece.There is no piece left into the patient.The device was used on the abdominal wall.No device was used after the issue to complete the case.No further information is available.

Manufacturer Narrative

(b)(4).Date sent: 12/22/2023.D4: batch # a9ce9n.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: "what is the surgeons experience with this device? ¿what is the patients bmi? ¿what is patients current status? ¿what action was being performed when the device broke? ¿what was the anatomical position of this specific port? ¿was there excessive torquing of the instrument at the time of the breakage? ¿what instruments were passed through the trocar? ¿has there been any re-operations/attempts to look for the pieces left in the patient? ¿does the account use reprocessed trocars or does the account reprocess the trocars in house at the account?" investigation summary the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the 2h12lp device was received with the olive plug assembly damaged.In addition, the broken part of the olive plug assembly was returned inside aplastic bag.As each device is visually inspected and functionally tested during the manufacturing process, no conclusion could be reached as to what might have caused the reported event.No conclusion could be reached as to what might have caused the reported event.The damaged on the olive plug assembly , it is possible that the damaged was due to an improper handling of the device.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 1/17/2024.Additional information was requested and the following was obtained: "what is the surgeons experience with this device? ? the sales rep tried the additional.Information but the additional information was not provided.What is the patients bmi? ? the sales rep tried the additional information but the additional information was not provided.What is patients current status? ? the sales rep tried the additional information but the additional information was not provided.What action was being performed when the device broke? after the vessels were treated.What was the anatomical position of this specific port? the sales rep tried the additional information but the additional information was not provided.Was there excessive torquing of the instrument at the time of the breakage? no.What instruments were passed through the trocar? the sales rep tried the additional information but the additional information was not provided.Has there been any re-operations/attempts to look for the pieces left in the patient? the incisional wound was added.Does the account use reprocessed trocars or does the account reprocess the trocars in house at the account? no.".

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 18192557
• MDR Text Key: 328810591
• Report Number: 3005075853-2023-08709
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036014256
• UDI-Public: 10705036014256
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2H12LP
• Device Lot Number: BATCH: A9CE9N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other