MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-07-31 for FLEXOR URETERAL ACCESS SHEATH AND DILATORS 076000-F120035 manufactured by Cook Inc.
[115580063]
Blank fields on this form indicate the information is unknown or unavailable. (b)(6). (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[115580064]
It has been reported the primary assistant of surgery got injured (left ring finger artery and nerve were dismembered) by the coil of the flexor ureteral access sheath, due to cutting the flexor sheath. As reported, the physician who got injured understands there was an error in usage. On (b)(6) 2018, the physician who got injured was the primary assistant of the percutaneous nephrolithotomy (pnl) surgery. Another physician who belongs to the same facility was the operating surgeon. The patient was anesthetized, intratracheal intubation, and positioned in a prone position. Then the patient was disinfected and covered by a drape. Two wire guides were inserted from right ileal conduit, then the ileal conduit was removed. One of the wire guides was fixed to the skin as a safety guide wire by the operating surgeon. To crush and remove the kidney stone through a flexible ureteroscope, a cook flexor 12/14fr 35cm was inserted by the operating surgeon until its tip reached the kidney pelvis over the other wire guide. At this point, the primary assistant physician attempted to affix the flexor sheath to the skin with silken thread. The operating surgeon suggested to cut the flexor sheath by scissors, because the flexor sheath was 35cm so it was too long from the body surface to handle the flexible ureteroscope. (the primary assistant was not sure if the sheath could be cut due to metal coil inside of the sheath. ) the operating surgeon attempted to cut the sheath and it was successful. However, when the primary assistant checked its lumen, the coil was smashed around the cut surface. So, it was impossible to insert the flexible ureteroscope. The primary assistant tried to pull the coil from the cut surface using the left thumb and left point finger. The coil was removed from the behind of the sheath more and more, and came off, then it cut primary assistant's left ring finger deeply. Bleeding could not be stopped due to arterial hemorrhage. The procedure was completed using another manufacturer's device. Since the sensation of the finger was in the periphery from the cut part, the primary assistant was delivered to the emergency room at (b)(6) hospital to perform surgery of artery and nerve rupture. Skin was sutured temporarily under interdigital nerve block. On (b)(6) 2018, neurorrhaphy (microsurgery) and suture skin were performed under general anesthesia. On (b)(6) 2018, the primary assistant was discharged from the hospital. The primary assistant has commented, even now ((b)(6) 2018), i cannot move the first joint of left ring finger, also peripheral sense is dull and has been continuing numbness. It is unknown whether the finger sense will return or not until follow the progress. I am focused on work that do not use hands such as outpatients, and i do not know whether i will be able to perform surgery again in the future. Although i am going to rehabilitate, in order not to recur such a thing again in the future, i think that it is necessary to pay close attention not to cut the sheath by scissor and not to touch the coil of the sheath with the hand. It is almost impossible to think about cutting the sheath with scissors in common sense, and it seems that there are hardly cases in which such things are needed. It is also hard to think that pulling out the coil by hand, but since the accident like the one above actually occurred, i contacted you for the purpose of preventing recurrence. An inquiry was made to determine the reason why the physician used a 35cm sheath. The response was that there was no stock of a shorter sheath at the facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02343 |
| MDR Report Key | 7735874 |
| Report Source | OTHER |
| Date Received | 2018-07-31 |
| Date of Report | 2018-09-11 |
| Date of Event | 2018-07-19 |
| Date Mfgr Received | 2018-08-29 |
| Date Added to Maude | 2018-07-31 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXOR URETERAL ACCESS SHEATH AND DILATORS |
| Generic Name | KOE DILATOR, URETHRAL |
| Product Code | KOE |
| Date Received | 2018-07-31 |
| Catalog Number | 076000-F120035 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-07-31 |