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 2019-01-28 for C8501, S ALEXIS LAP SYS 6/BX 101357001 manufactured by Applied Medical Resources.
[136611141]
The event unit returns for evaluation. A follow-up report will be provided upon completion of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[136611142]
Name of procedure being performed: laparoscopic sigmoid resection. Detailed description of event cer 1 of 2: (b)(4), cer 2 of 2: (b)(4). When the alexis cap was removed at the end of the surgery, dr. [name] saw the torn-off piece of the double duckbill and could remove it without issues. A cff73 was used as abdominal port in the cap. The same incident had occurred shortly before already, however the cap has been disposed of here. Additional information received from applied team member, via email on 09jan2019: "i know that for (b)(4), the complaint was that a piece of the duckbill was found in the abdominal cavity. The other incident was that it was torn, but not detached. " additional information received from sales representative by email on 09jan2019: questions asked: how was the trocar used? Did the customer inflate the balloon and tension it against the duckbill? Was the balloon inflated when the trocar was removed from the laparoscopic cap? Was this the first time that the surgeon used the cff73 and the c8501 together in the surgery? Responses received: the cff73 was used initially as instrument trocar and then in the alexis cap as i saw in the last lap sigma the balloon was inflated but no tension against the duckbill-valve no, the trocar wasn? T inflated when removed because when they? Re finished they pull off the cap with the trocar inside. This was not the first time that the cff73 was used together with the c8501. Since they use this article they use as well the cff73 and sometimes they? Ve used as well a reusable trocar together with the cap. Additional information received from sales representative by phone on 10jan2019: is the customer also sending the torn-off piece back (for cer (b)(4))? Yes. Was additional force used to insert the trocar into the laparoscopic cap? No. The 12mm is the largest diameter used, larger is not possible because the seal is so stiff. The customer sometimes uses 10mm. Were there any issues inserting the trocar into the laparoscopic cap? No. Was an obturator used to insert the trocar into the laparoscopic cap? Unknown, unlikely. They usually insert it without obturator, and never order the alexis lap model with the z-thread trocar. If so, what kind of obturator did the customer use? Was it the accompanying fios obturator that comes with the cff73? N/a. Was there a lot of angulation with the instruments that were inserted through the trocar? No. Has the trocar been removed from the cap and replaced during the procedure? No. Trocar was inserted into the cap, then the cap was placed on the alexis. How long (approximately) have the cap and trocar been used together? 1 hour max, in a surgery of approximately 4 hours. Concomitant device: cff73. Patient status: no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2019-00329 |
| MDR Report Key | 8282054 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-28 |
| Date of Report | 2019-02-25 |
| Date of Event | 2018-12-17 |
| Date Mfgr Received | 2019-01-07 |
| Date Added to Maude | 2019-01-28 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C8501, S ALEXIS LAP SYS 6/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2019-01-28 |
| Returned To Mfg | 2019-01-24 |
| Model Number | C8501 |
| Catalog Number | 101357001 |
| Lot Number | UNKNOWN |
| 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 EMPRSA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-28 |