MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-25 for SPACEMAKER SMBTTOVLX manufactured by Us Surgical Puerto Rico.
[185244998]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185244999]
According to the reporter, during a laparoscopic total extra peritoneal inguinal hernia repair, on access and dissection, the balloon split in half. A new balloon was opened to complete the case. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[189082637]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. The visual inspection of the returned product noted: that the dissector balloon, trocar balloon, lock collar, obturator and insufflation bulb appeared intact. The inflation syringe was not received. A functional evaluation found that using a test syringe the trocar balloon was inflated, no leaks detected. The dissector balloon was inflated, a leak was detected. A hole was observed. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Replication of the hole in the dissector balloon may occur when mishandled during clinical application. As per instructions for use (ifu), caution : care must be exercised during insertion of the balloon as well as during the course of the procedure to avoid damaging the balloon with other instruments. The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition. No further actions have been deemed necessary at this time. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647580-2020-01072 |
| MDR Report Key | 9876665 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-11-12 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | US SURGICAL PUERTO RICO |
| Manufacturer Street | 201 SABANETAS INDUSTRIAL PARK |
| Manufacturer City | PONCE PR 007164401 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 007164401 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPACEMAKER |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | GCJ |
| Date Received | 2020-03-25 |
| Model Number | SMBTTOVLX |
| Catalog Number | SMBTTOVLX |
| Lot Number | P9L1083Y |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | US SURGICAL PUERTO RICO |
| Manufacturer Address | 201 SABANETAS INDUSTRIAL PARK PONCE PR 007164401 US 007164401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |