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

Catalog Number 2CB12LT

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2019

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.

Event Description

It was reported that during set-up for a lap nephrectomy case and prior to the trocar being inserted into the patient, the trocar would not go through the sleeve.Staff noticed that it was jammed due to the internal sleeve on the trocar being broken.A second trocar was used in place of the damaged one.There was no patient consequence.

Manufacturer Narrative

(b)(4).Batch # unk.Investigation summary: the analysis results found that 2cb12lt device was received with the absorbent not properly assembled on the sleeve housing.Complaint was confirmed.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Corrected data: batch # is t40r0p.A manufacturing record evaluation was performed for the finished device lot/batch number and no non-conformances were identified.

• Brand Name: OPT SLEEVE 12X100 STABILITY
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9282271
• MDR Text Key: 181974886
• Report Number: 3005075853-2019-23259
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036014263
• UDI-Public: 10705036014263
• Combination Product (y/n): N
• PMA/PMN Number: K122512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 2CB12LT
• Device Lot Number: T40R0P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Date Manufacturer Received: 12/20/2019
• Patient Sequence Number: 1