MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,use report with the FDA on 2015-07-24 for NCIRCLE NITINOL HYSTERSCOPIC POLYP SNARE N/A J-NTSE-050035-UDH-HPS manufactured by Cook Inc.
[6034153]
During a hysteroscopy procedure on a female patient, the tips of the snares broke off, remaining within the patient. This occurred with 3 devices during the same procedure 2 each from the same lot (1820334-2015-00464) and 1 of a different lot (1820334-2015-00464) and 1 of a different lot (1820334-2015-00456). The broken pieces were successfully removed (method was not provided) and disposed of. The procedure was successfully completed with another device. According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[13965614]
Snare, surgical. J-ntse-050035-udh-hps. (b)(4). (b)(4) the event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[34454942]
Common device name: snare, surgical. (b)(4). Event evaluation: a review of the complaint history, device history record, drawing, manufacturing instructions, instructions for use (ifu) quality control, along with a functional test and visual inspection of returned products was conducted during the investigation. The customer returned two used snare devices; one was visibly damaged, the other did not show outward signs of damage. The returned devices were examined for function and damage. The first device was visibly damaged. The basket handle did actuate the outer sheath as it would normally open and close the basket. However, the basket formation did not occur because the outer sheath was fractured with two splits running lengthwise. One was approximately 2cm in length, the other on the opposite side of the sheath was about 1cm in length. One of the 4 basket wires was fractured from the notched cannula. There is also a kink in the outer sheath at 4cm distal from the handle. It appears that excessive force was applied to this device. The second device did not show any outward signs of damage. The handle did actuate the basket formation. All 4 basket wires were attached to the notched cannula and were secure when tugged on individually. The basket wires were looped together as specified in the drawing. The damage or tip separation on this device is not apparent upon investigation. There is no evidence to suggest that the device was not manufactured to specification. The device is shipped with ifu which gives device description, intended use, warnings, precautions and contraindications regarding proper use of the device. The ifu includes the precaution that "excessive force could damage the device. " based on examination of both devices we are unable to determine the cause of the root cause of the incident with certainty. However, it does appear highly likely that in the case of one of the two devices, use of excessive force could have led to the device failure. We have notified the appropriate internal personnel and will continue to monitor for similar events. Per the conclusion of the quality engineering risk assessment, further risk reduction is not required.
Patient Sequence No: 1, Text Type: N, H10
[34454943]
During a hysteroscopy procedure on a female patient, the tips of the snares broke off, remaining within the patient. This occurred with 3 devices during the same procedure 2 each from the same lot (1820334-2015-00464) and 1 of a different lot (1820334-2015-00456). The broken pieces were successfully removed (method was not provided) and disposed of. The procedure was successfully completed with another device. According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2015-00464 |
| MDR Report Key | 4947120 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2015-07-24 |
| Date of Report | 2015-07-02 |
| Date of Event | 2015-07-02 |
| Date Facility Aware | 2015-07-02 |
| Report Date | 2015-07-02 |
| Date Mfgr Received | 2015-07-06 |
| Device Manufacturer Date | 2014-12-18 |
| Date Added to Maude | 2015-07-29 |
| 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 | MEDICAL ASSISTANT |
| 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 | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NCIRCLE NITINOL HYSTERSCOPIC POLYP SNARE |
| Generic Name | GAE SNARE, SURGICAL |
| Product Code | GAE |
| Date Received | 2015-07-24 |
| Returned To Mfg | 2015-07-21 |
| Model Number | N/A |
| Catalog Number | J-NTSE-050035-UDH-HPS |
| Lot Number | 5468557 |
| Device Expiration Date | 2017-11-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2015-07-24 |