MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-02-08 for CONNOR WAND AH7100 manufactured by Accutome, Inc..
[18617797]
The tip of a straight connor wand broke off inside the eye during a procedure on (b)(6) 2009. At the time of surgery the tip could not be visualized and it was assumed that it had been removed through the phaco handpiece. Several weeks after the surgery during a postoperative visit the tip was seen in the anterior chamber. The patient was returned to the operating room on (b)(6) 2009 where the tip was retrieved from the eye. On (b)(6) 2009 a meeting was convened to discuss the incident. (b)(4). It was determined in this meeting that no recall of the instrument was needed as it was an isolated event. This was the first occasion accutome had been made aware of connor wands breaking. As of the year 2000 a total of (b)(4) stainless steel straight connor wands have been sold without further incident involving a patient. In the case of (b)(6), the customer had purchased a total of (b)(6) conner wands ((b)(6) in 2003, (b)(6) in 2005, (b)(6) in 2006 and (b)(6) in 2007). They have also had a total of (b)(6) connor wands repaired ((b)(6) in 2005, (b)(6) in 2007 and (b)(6) in 2008). Also factoring in accutome's decision to not issue a recall is the fact that the physician performing the procedure bore some responsibility in the occurrence of this event. The physician and/or the staff is responsible for inspecting all instruments prior to surgery. This is documented on the warning card that is included with all accutome instruments and repairs. If any of the instruments, in this case the connor wand had been deemed questionable then it should not have been used.
Patient Sequence No: 1, Text Type: D, B5
[18696344]
(b)(4). On (b)(6) 2009 a fax from (b)(6) was received, notifying accutome of an incident that occurred in their facility involving one of our products. According to the fax received the tip of the straight connor wand broke off inside the eye during a procedure on (b)(6), 2009. At the time of surgery the tip could not be visualized and it was assumed that it had been removed through the phaco handpiece. Several weeks after the surgery during a postoperative visit the tip was seen in the anterior chamber. The patient was returned to the operating room on (b)(6) 2009 where the tip was retrieved from the eye. (b)(6) also noted in the fax that the tips of several other accutome connor wands had broken off in the past, but never in the patient's eye. They have since replaced all accutome stainless connor wands with equivalent titanium measurements. Additionally, the physician's assumption that the broken tip had been removed by the phaco handpiece was careless at a minimum. Though the broken tip may have been difficult to visualize an exhaustive search should have been conducted until the broken tip could be located, whether it resided in the patient's eye or in the phaco machine. In response accutome will no longer sell a stainless steel version of the straight connor wand, selling only a titanium version. Additionally, accutome will no longer repair either the stainless steel or titanium versions of the connor wand.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2521877-2011-00001 |
| MDR Report Key | 1982217 |
| Report Source | 05,06 |
| Date Received | 2011-02-08 |
| Date of Report | 2011-02-08 |
| Date of Event | 2009-06-22 |
| Date Added to Maude | 2011-02-10 |
| 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 | BRIAN BARRETT |
| Manufacturer Street | 3222 PHOENIXVILLE PIKE |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6108890200 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Removal Correction Number | CAPA A132 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONNOR WAND |
| Generic Name | OPHTHALMIC SPATULA |
| Product Code | HND |
| Date Received | 2011-02-08 |
| Model Number | AH7100 |
| Catalog Number | AH7100 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCUTOME, INC. |
| Manufacturer Address | MALVERN PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-02-08 |