Device product
Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.
Z-2608-2016
Product summary
- Event
- Event 74656
- Status
- Terminated
- Classification
- Class II
- Quantity
- Product code 8378.90- 94 pieces & Product code 8378.91 - 32 pieces
- Official record key
device-enforcement:Z-2608-2016
Official wording
Reason: The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the impacted batches of product, the weld was improperly performed. As a result, the two pieces are not properly joined. This potential failure can result in the separation of the two pieces. The possible separation of these two components presents a potential risk to patients.
Code information: Product number 8378.90 with Batch number 51005921 and Product number 8378.91 with Batch number 51005922
Distribution pattern: U.S. Consignees: AK, AL, AR, AZ, CA, CT, DC, FL, GA, IA, IL, KY, MA, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, TX, UT and VA.
Derived failure modes
-
Unknown
The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the impacted batches of product, the weld was improperly performed. As a result, the two pieces are not properly joined. This potential failure can result in the separation of the two pieces. The possible separation of these two components presents a potential risk to patients.