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

Model Number B11LT

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2020

Event Type  malfunction  

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 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).

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
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10610938
• MDR Text Key: 209425229
• Report Number: 3005075853-2020-05080
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001126
• UDI-Public: 10705036001126
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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 Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 10/23/2020
• Patient Sequence Number: 1