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

Model Number	H12LP
Medical Device Problem Codes	Use of Device Problem (1670); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # v9555a.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance / manufacturing irregularities were identified.As part of our quality process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.If the product is received at a later date, the investigation will be updated as applicable.Additional information received: a photo was received for review.During the visual analysis, the following was observed: the photo shows an h12lp universal with a piece of torn seal also observed to be placed on a cap.No packaging was observed in the photo provided.Based on the photo, the event described was confirmed, however no conclusion or root cause could be determined.Because the instrument was not returned, the evaluation is limited.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.
Event or Problem Description
It was reported that during a laparoscopic appendectomy, the surgeon found black pieces of the universal trocar seal fell into the patient.A large piece was found and removed but there was a little piece that was missing from the larger piece that was not found, though they used a laparoscope and grapsers to search the abdominal cavity for additional pieces.It was noted that several items were used down this trocar port including an ats45, grasper, specimen retrieval bag, and a raytec sponge.The appendix was also removed through this port using a specimen retrieval device.The patient has not experienced any issues since procedure and there is no plan for any reoperation to locate tiny seal piece.

• 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 ; * 00969
• MDR Report Key: 12628748
• Report Number: 3005075853-2021-06174
• Device Sequence Number: 13796922
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H12LP
• Device Catalogue Number: H12LP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other