MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	B11LT
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon using 11 mm trocar with 30 degree 5 mm scope, he saw sharding in the obturator.This did not affect the patient, did not enter the abdominal cavity, but hindered the surgeon¿s view while entering the peritoneal cavity.There was no delay to procedure and there was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Batch # 353a20.Date of event is 2021, event day and month unknown.Captured as (b)(6) 2021.Additional information received: photos were received for review.Review is in progress and has not yet been completed.Upon completion of photo review, a supplemental medwatch will be sent.Additional information was requested and the following was provided: please provide more details about ¿shading¿, were like blind spots in trocar? or if not, what does sharding mean? the surgeon referred to the obturator ¿sharding¿ meaning that pieces of the plastic within the obturator had sharded (broke, chipped, fragmented).The pieces of plastic remain within the obturator and do not enter the patient, but it does affect visibility while he is entering the abdominal cavity.A manufacturing record evaluation was performed for the finished device lot/batch number and no non-conformances were identified.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our quality process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.If the product is received at a later date, the investigation will be updated as applicable.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4) date sent: 2/10/2022 h2: additional information received: four photos were received for review.During visual analysis, the following was observed: the first photo shows a monitor with a image of the clear lens.The second, third, and fourth photos show the clear lens cracked of the obturator.Based on the set of photos reviewed, the event described is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned, our evaluation is limited.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/batch number, and no non-conformances were identified.

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR
• Common Device Name: 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: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13192605
• Report Number: 3005075853-2022-00131
• Device Sequence Number: 19897912
• Product Code: GCJ
• UDI-Device Identifier: 10705036001126
• UDI-Public: 10705036001126
• Combination Product (Y/N): N
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: B11LT
• Device Catalogue Number: B11LT
• Device Lot Number: 353A20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown