MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-03-23 for AUTO SUTURE OMS-T10BT manufactured by Us Surgical Puerto Rico.
[184492648]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184492649]
According to the reporter, prior to use, two balloon ports were torn. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[188945970]
Evaluation summary: post market vigilance (pmv) led an evaluation of two device. The visual inspection of the returned product noted: the trocar balloons, lock collars, valve seals and doors appeared to be intact. The obturators were received. The inflation syringes were received. A functional evaluation found that the balloons were inflated; leaks were detected and cuts were observed. The flapper valves when actuated opened and closed securely. The lock collars moved up and down the cannula and snapped securely on place. The obturators were inserted into the trocars and cannula, they were removed without restriction. 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 cut in the 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 due to the product 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 | 2647580-2020-01034 |
| MDR Report Key | 9866254 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-07-11 |
| Date Added to Maude | 2020-03-23 |
| 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 | AUTO SUTURE |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | GCJ |
| Date Received | 2020-03-23 |
| Model Number | OMS-T10BT |
| Catalog Number | OMS-T10BT |
| Lot Number | P9G1034Y |
| 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 | 2020-03-23 |