MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT SLEEVE 5X100MM STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	2CB5LT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Only event year known: 2019.Batch # unk.Attempts have been 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.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information was requested, and the following was obtained: just for clarification, when the trocar sleeve was broken during the insertion into the patient, did the sleeve break into multiple pieces? if yes, did any piece or pieces fall into the patient? if yes, were they removed? will all pieces be returned for analysis? were there any patient consequences? response: the trocar broke into two pieces.Both pieces are being returned.I don't know the details, but he said he had to remove from the patient, no patient consequences.
Event or Problem Description
It was reported that during an unknown procedure the sleeve of the trocar broke off while insertion into the patient.It was not reported how the procedure was completed.There were no patient consequences reported.This is all the information known/available regarding this event.
Additional Manufacturer Narrative
(b)(4).Batch # t92m8n; t92p55; t92p55.Investigation summary: the analysis results found that the 2cb5lt instrument was received with the sleeve melted.In addition, the tyvek was returned along with the instrument.This type of damage is consistent with the one produced by an energized device.In order to prevent this kind of damage please avoid the contact with laser, electrosurgical, or ultrasonic devices.A manufacturing record evaluation was performed for the finished device lot and batch numbered and no non-conformance's were identified.

• Brand Name: OPT SLEEVE 5X100MM STABILITY
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8841240
• Report Number: 3005075853-2019-20874
• Device Sequence Number: 372340
• Product Code: GCJ
• UDI-Device Identifier: 10705036013730
• UDI-Public: 10705036013730
• Combination Product (Y/N): N
• Initial Reporter State: MI
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2019

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: 02/29/2024
• Device Catalogue Number: 2CB5LT
• Device Lot Number: T4086J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/09/2019
• Patient Sequence Number: 1