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

Catalog Number	2CB12LT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2019
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.
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9282271
• Report Number: 3005075853-2019-23259
• Device Sequence Number: 17044904
• Product Code: GCJ
• UDI-Device Identifier: 10705036014263
• UDI-Public: 10705036014263
• Combination Product (Y/N): N
• PMA/510(K) Number: K122512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2019

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: 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
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 12/20/2019; 12/20/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/11/2019; 12/11/2019
• Patient Sequence Number: 1