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

Model Number	H12LP
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts are being made to obtain additional information and to retrieve the device.To date, the device has not been returned and no additional information has been received.If the device or further details are received at a later date a supplemental medwatch will be sent: please confirm which portion of the trocar was cracked.Was the trocar sleeve? if other, please specify.Please provide the status of the device(s) as it has not been received for analysis.Additional information received: two photos were received for review.Review is in progress and not yet completed.Upon completion of photo review, a supplemental medwatch will be sent.
Event or Problem Description
It was reported that during an unknown procedure, the trocar was cracked while inserting the port.There was no delay to procedure.It is unknown how procedure was completed.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/18/2020.D4: batch # unk.H2: additional information received: two photos were received for review.Upon visual inspection of two photos, the following was observed: picture one shows a close up view of the lot number t41144, expiration date 2024-10-31 and bar codes of the back of the package of a 12mm xcel trocar.Picture two shows the trocar inside a plastic bag along with the tyvek.Photo resolution does not allow for a clear view of the alleged failure.Based on the photos, the event described cannot be confirmed.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/4/2021 h2: additional information received: sale reps informed that it was crack on the housing of trocar.(b)(4).Date sent: 1/4/2021 h11=corrected data=h1; h6 h1: mdr decision is now not reportable.H6: the device did not have a cracked sleeve so crack (a0404), medical device problem code, should be removed.Upon review of the additional information that was provided (see additional narrative in h10), it was concluded that this event no longer meets the fda defined criteria for a reportable event and is now being considered not reportable.

• Brand Name: ENDOPATH XCEL BLUNT TIP TROCAR
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10988941
• Report Number: 3005075853-2020-06693
• Device Sequence Number: 3487185
• Product Code: GCJ
• UDI-Device Identifier: 10705036002017
• UDI-Public: 10705036002017
• Combination Product (Y/N): N
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2020

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: 10/31/2024
• Device Model Number: H12LP
• Device Catalogue Number: H12LP
• Device Lot Number: T41144
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 11/25/2020; 12/24/2020
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 12/18/2020; 01/04/2021
• Patient Sequence Number: 1