MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04,07 report with the FDA on 2015-07-29 for SANI-SCOPE DISP ANOSCOPE 82420 manufactured by Coopersurgical, Inc..
[23393955]
A review for the 2 year complaint history for the sani-scope disp anoscope showed (b)(4) similar complaint. The sani-scope disp anoscope has not had any related product design or product specification changes in the last 2 years. The sani-scope disp anoscope is a purchased product and it is not lot controlled. A 2 year review of incoming inspection records shows the sani-scope disp anoscope were to specification upon receipt. The last shipment of sani-scope disp anoscope to (b)(4) prior to this complaint was 6/22/2015. A review of fg inventory was done at c=0 aql 1. 0 ((b)(4) pieces). The review and inspection showed the ((b)(4)) sani-scope disp anoscope were to specification. There was no separation of the round tip. The reported condition could not be confirmed as the actual sample was not returned. The complaint will be re-opened and re-evaluated if additional information or the sample becomes available. An assignable cause could not be determined as the product met all approved release specifications at the time of manufacture before they were released. Likely cause of the reported complaint condition is concealed damage due to mishandling during shipping and or excessive pull force exceeding the 15lb specification. Coopersurgical will continue to monitor this complaint condition for any trends. No corrective action needed by coopersurgical at this time. This complaint will be entered into coopersurgical's continuous improvement program (cip). All complaints in the cip program are trended and reviewed on a quarterly basis by management at coopersurgical to determine appropriate course of action.
Patient Sequence No: 1, Text Type: N, H10
[23393956]
It was reported that the anoscope - part number 82420 - broke off inside the patient and had to be retrieved. Reference e-complaint number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2015-00043 |
| MDR Report Key | 4955924 |
| Report Source | 00,04,07 |
| Date Received | 2015-07-29 |
| Date of Report | 2015-07-20 |
| Date of Event | 2015-06-25 |
| Date Mfgr Received | 2015-06-25 |
| Date Added to Maude | 2015-08-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NANA BANAFO |
| Manufacturer Street | 75 CORPORATE DR. |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SANI-SCOPE DISP ANOSCOPE |
| Generic Name | SANI-SCOPE DISP ANOSCOPE |
| Product Code | FER |
| Date Received | 2015-07-29 |
| Model Number | 82420 |
| Catalog Number | 82420 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | TRUMBULL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-29 |