MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-15 for C8701, S ALEXIS LAP SYS W/KII FIOS 5/BX 101135801 manufactured by Applied Medical Resources.
[145798949]
The incident device is anticipated to return. A follow-up report will be provided upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
[145798950]
Name of procedure being performed: prostatectomy da vinci. Detailed description of event: after retrieving the prostate, the cap was placed on the alexis, the ctf71 inserted and insufflated. The patient was sufficiently relaxed according to [name] and did not press. After a short moment, there was a bang, the cap flew off, intestinal loops bulged out of the incision and the foil of alexis was damaged. The optic had not been introduced at this time. The general surgeons were consulted and after inspecting the bowels their could not find any injuries. [name] himself was not in the room during the procedure. I will be there tomorrow morning and speak with the directly involved. Additional information received from sales representative by email on 01may2019: i talked to the involved people in the meantime and they described the event as follows: after the fascia sutures were applied, the alexis was inserted into the incision at the beginning of the procedure. The cap was placed on the alexis, the da vinci metal trocar introduced and insufflated. After a short moment there was a loud bang and the intestinal loops bulged laterally through the crack in the foil. The cap remained on the outer white ring. A perforation of the foil by the metal trocar could be excluded by the surgical staff. According to anesthetist, the patient has not pressed. The insufflator was checked and showed no defect. The patient has a bmi of 42, had 2 surgeries before - but there was no foreign material such as mesh or clips in the wound margin. The patient has not been harmed by the incident. Additional information received from sales representative by email on 03may2019: did the lap cap fly off the alexis during the procedure or was the lap cap secured on the outer white ring the entire time (there seems to be a discrepancy in the incident description)? The cap has not flown off as reported first by mistake. Did the bowel come out of the alexis after removing the lap cap? No. Where exactly was the location of this incision? At the umbilicus. Roughly how much time had transpired from when the cap was placed onto the alexis to when the incident occurred? A few seconds (7 to 10). Was the target insufflation pressure reached? Yes. What was that pressure? 15 mmhg. When the incident occurred, what was the indicated insufflation pressure? 15 mmhg. Which trocar or trocars were going through the cap at the time? If there was more than one, how were they arranged? Only the da vinci trocar was inserted in the cap. Where was the insufflation tubing connected to? To the da vinci trocar in the alexis cap (first trocar). Was any instrumentation or scope passed through the trocars or cap leading into this incident? No, as this event happened at the beginning of the surgery. Additional information received from sales representative by email on 06may2019: which model of the da vinci robot was used / what was the diameter of the metal trocar used? Da vinci xi with 8 mm da vinci trocar. Additional info states that the metal da vinci trocars were used, and not the ctf71 as stated in the first report. Why did the hospital choose to use the c8701 (and not the c8501), if they were not using the trocar? They use the ctf71 as the auxiliary trocar. Can we be sure the metal da vinci trocar was not placed through the ctf71? Yes. What size incision did the surgeon make to place the alexis? Approx 3. 5 to 4 cm. At what part of the procedure was the alexis laparoscopic system placed? In the first statement it says the cap was placed after retrieving the prostate (which is towards the end of the surgery), wrong information was given first in the additional information it states "the alexis was inserted into the incision at the beginning of the procedure. The cap was placed on the alexis, the da vinci metal trocar introduced and insufflated. " that? S correct! Depending on this, can any instrumentation have come into contact with the alexis sheath? Definitively no. Type of intervention: inspection of the bowel. Patient status: no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2019-00451 |
| MDR Report Key | 8614028 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-15 |
| Date of Report | 2019-07-30 |
| Date of Event | 2019-04-29 |
| Date Mfgr Received | 2019-04-29 |
| Device Manufacturer Date | 2018-12-31 |
| Date Added to Maude | 2019-05-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | WENDY KOBAYASHI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C8701, S ALEXIS LAP SYS W/KII FIOS 5/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2019-05-15 |
| Returned To Mfg | 2019-05-24 |
| Model Number | C8701 |
| Catalog Number | 101135801 |
| Lot Number | 1344215 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-15 |