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

Catalog Number	B11LT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 9/12/2024.B3: unknown, assumed first day of month that complaint was reported.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.D4: batch # unk.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that only two(2) sleeve from the b11lt devices were returned.One(1) sleeve was returned with the the universal seal broken and with tip melted, one(1) sleeve was returned with the housing cap component disassembled from the housing and the with the tip broken.No conclusion could be reached as to what may have caused the reported incident.It should be noted that product failure is multifactorial.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through ethicon¿s quality system.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.The manufacturing records couldn't be reviewed as the batch number is unknown.
Event or Problem Description
The device was received with no complaint information.Attempts were made to reconcile the device with no success resulting in the creation of a new complaint.

• 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 20200794
• Report Number: 3005075853-2024-06823
• Device Sequence Number: 18019224
• Product Code: GCJ
• UDI-Device Identifier: 10705036001126
• UDI-Public: 10705036001126
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

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 Catalogue Number: B11LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown