MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8701, S ALEXIS LAP SYS W/ KII FIOS 5/BX; KGW

Model Number	C8701
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of investigation.There is no report of serious injury or death associated with this event.
Event or Problem Description
Radical prostatectomized vinci - obviously the anesthesia (relaxation) was to low that the muscle contraction of the patient was higher, this let to the fact that the intra abdominal pressure increase enormous.As the consequence the shaft of the als tore and the cap of the system popped off with an extreme loud sound.Patient is fine.The trocars had to be replaced with a minimal elongation of the procedure time.Additional information received from (b)(4) march 16 2017: after the cap blew off, there was rapid loss of pneumoperitoneum.The incident occurred during the procedure, so instruments were being passed through when this happened.There were davinci instruments in use.When the cap popped off, they immediately removed the arms of the davinci additional information received from (b)(4) on 24 march 2017: there was a trocar inserted through the cap, the 12 mm kii fios z-thread that is included with the alexis lap.Patient status - "did a patient injury or illness occur associated with the complaint event? no.".
Additional Manufacturer Narrative
The event unit was returned for evaluation.Upon evaluation, engineering confirmed the alexis® unit had a large horizontal tear in the sheath and one small vertical tear along the horizontal tear line.The laparoscopic cap was not returned.Engineering attempted to replicate the sequence of events described by the complainant; however, they were unsuccessful.It is likely that the tear was caused by the instrumentation used by the surgeon.The small vertical tear is most likely the origin of the large horizontal tear found in the film.The complainant stated that the intra-abdominal pressure was high during the surgery and it is likely that this may have led to the loud sound when the sheath tore.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
Event or Problem Description
Additional information received from applied medical team member on april 10, 2017: the cap was still attached to the wound retractor when the pop occurred.The tear was noticed after the cap popped off.There was no damage to the cap.There is no footage of this laparoscopic case.Additional information received from rsm on 25 april 2017: it is unknown at which pressure the abdomen was being insufflated.

• Brand Name: C8701, S ALEXIS LAP SYS W/ KII FIOS 5/BX
• Common Device Name: KGW
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6456926
• Report Number: 2027111-2017-01646
• Device Sequence Number: 621668
• Product Code: KGW
• UDI-Device Identifier: 00607915125714
• UDI-Public: (01)00607915125714(17)191123(30)01(10)1283543
• Combination Product (Y/N): N
• PMA/510(K) Number: K093296
• 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
• Report Date (Section B): 05/31/2017

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: Other
• Device Expiration Date: 11/23/2019
• Device Model Number: C8701
• Device Catalogue Number: 101135801
• Device Lot Number: 1283543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI ARM