MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-03-30 for ENDOSCOPIC DISSECTOR RGBRS1 manufactured by Obtech Medical Sarl_.
[5596086]
It was reported that during a laparoscopic duodenal switch procedure the tip of the device fell into the patient and the surgeon could not find it to remove it. The case was completed with another device of the same product code. The patient is not experiencing any issues. No patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
[13099620]
(b)(4). Should the information be provided later, a supplemental medwatch will be sent. Additional information requested and received: what is the patient's status? Unknown. Will further attempts be made to recover the missing component(s) from the patient? Unknown. At what point did the tip fall into the patient? During use of the device intra-op? ; upon removal of the device through the trocar etc. Please specify. Upon removal of device from trocar. When you refer to the tip, are you referring to the gold colored tip at the end of the device or part of the black casing near the tip of the device? Gold tip. What size trocar was used? Unknown. Was there any resistance felt when removing the dissector from the trocar? Unknown were any other medical accessories, specifically heat producing, electro-surgery or ultrasound energy accessories, in use at the time of the surgery? Unknown the device was returned in protective packaging with the lever of the handle housing engaged and the distal tip curved at a 90 degree angle. The tip of the distal end was missing where the suture would normally be attached upwards. The? Break line? Is evident on the suture notch of the distal tip (where the suture is snared). The flex shroud is in-tact. There are 4 scratch lines visible on the flex shroud closest to the gold tip at the distal end. This may be due to trocar insertion or extraction. The complaint is confirmed. The tip appears to have been broken off. No surface defects were visible that would indicate the product was used in close proximity of medical accessories such as electro-surgery or ultrasound energy devices. The tip of the distal end of the endoscopic dissector was not returned with the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005992282-2015-00010 |
| MDR Report Key | 4641639 |
| Report Source | 06,07 |
| Date Received | 2015-03-30 |
| Date of Report | 2015-03-05 |
| Date of Event | 2015-03-02 |
| Date Mfgr Received | 2015-03-05 |
| Device Manufacturer Date | 2014-11-24 |
| Date Added to Maude | 2015-03-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | GUILLERMO VILLA |
| Manufacturer Street | ROUTE 22 WEST PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082180707 |
| Manufacturer G1 | OBTECH MEDICAL SARL |
| Manufacturer Street | CHEMIN-BLANC 38 |
| Manufacturer City | LE LOCLE CH-2400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-2400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOSCOPIC DISSECTOR |
| Generic Name | DISSECTOR, SURGICAL, GENERAL AND PLASTIC SURGERY |
| Product Code | GDI |
| Date Received | 2015-03-30 |
| Returned To Mfg | 2015-03-25 |
| Model Number | NA |
| Catalog Number | RGBRS1 |
| Lot Number | ZTBBBW |
| Device Expiration Date | 2019-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBTECH MEDICAL SARL_ |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE CH-2400 SZ CH-2400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-30 |