MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. FLEXIPATH*SURG TROCAR 7MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	FP007
Medical Device Problem Codes	Crack (1135); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Additional information received: two photos were received for review.During the visual analysis, the following was observed: the photos show a flexible path 7mm trocar totally separated from the following parts: sliding push ring, sleeve placement line, obturator handle.Also, the trocar appears to be clean.Based on the photos, the event described is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may have provided the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned, our evaluation is limited.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing documentation could not be completed as the lot/batch number was not provided.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
T was reported that during a right pleural effusion procedure, an fp007 trocar broke when used in patient.Surgery was delayed an unknown amount of time, however procedure was successfully completed.There was no patient consequence.

• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 12741824
• Report Number: 3005075853-2021-06622
• Device Sequence Number: 19955723
• Product Code: GCJ
• UDI-Device Identifier: 10705036011903
• UDI-Public: 10705036011903
• Combination Product (Y/N): N
• PMA/510(K) Number: K931111
• 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
• Report Date (Section B): 11/02/2021

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 Model Number: FP007
• Device Catalogue Number: FP007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 11/02/2021
• Patient Sequence Number: 1