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

Model Number	B11LT
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts are being 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.
Event or Problem Description
It was reported that prior to a laparoscopic cholecystectomy, they opened up device, and there was a piece missing, the flapper door.They opened up another device to complete the case.There was no patient contact (no patient consequence).
Additional Manufacturer Narrative
(b)(4).Date sent: 10/23/2020.Investigation summary: the analysis results found that the b11lt device was returned with the scope locking cam (housed in obturator handle) missing.In addition, the tyvek was returned along with the instrument.No conclusion could be reached as to how this issue occurred.We have documented the circumstances as they were reported to us.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.

• 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
• MDR Report Key: 10610938
• Report Number: 3005075853-2020-05080
• Device Sequence Number: 16894950
• Product Code: GCJ
• UDI-Device Identifier: 10705036001126
• UDI-Public: 10705036001126
• Combination Product (Y/N): N
• Initial Reporter State: WY
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: 01/31/2025
• Device Model Number: B11LT
• Device Catalogue Number: B11LT
• Device Lot Number: U4041N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/23/2020
• Patient Sequence Number: 1